[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stemi---st-elevation-myocardial-infarction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stemi---st-elevation-myocardial-infarction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,51,83,116,145,165,187,212,239,263,289,311,337,363,390,412,432,456,498],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100545664","diagnostic-performance-of-artificial-intelligence-algorithms-in-prediction-of-acute-coronary-syndrome-based-on-white-blood-cell-properties-100545664",false,"NCT06384846","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties","Diagnostic Performance of Artificial Intelligence Algorithms in Prediction of Acute Coronary Syndrome Based on White Blood Cell Properties (AI-ACS Trial)","Inclusion Criteria:\n\nGeneral inclusion criteria:\n\n* Male or female, aged 18 years or above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Collection of WBC and hs-cTn data must be possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled, where applicable.\n\nCase cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* For patients qualifying for observation according to ESC guidelines, coronary angiography is not mandatory and time limits do not apply.\n* Confirmation of STEMI or NSTE-ACS by identification of a culprit lesion using coronary angiography; identical evaluation results by review board required.\n* For observation patients without coronary angiography, final discharge diagnosis is used to decide about the presence or absence of NSTEMI and\u002For ACS.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nControl cohort:\n\n* Suspicion of STEMI or NSTE-ACS according to current ESC guidelines.\n* Coronary angiography must have been performed within 72 hours after initial suspicion of ACS.\n* No identification of a culprit lesion compatible with diagnosis of STEMI or NSTE-ACS during coronary angiography; identical evaluation results by review board required.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nSupplementary cohort:\n\n* Subject presents without chest pain or with stable angina pectoris.\n* No indication for revascularization during coronary angiography; identical evaluation results by review board required.\n* Exclusion of elevated hs-cTn.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n* Between initial blood sampling to collect WBC data and coronary angiography, the subject must not develop suspicion of ACS.\n\nRule-out cohort:\n\n* Suspicion of NSTE-ACS and NSTEMI rule-out according to current ESC guidelines, i.e. very low initial hs-cTn value, or low initial hs-cTn value and no significant 1-hour\u002F2-hour change in hs-cTn value.\n* No coronary angiography within 72 hours.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data must be fulfilled.\n\nAll-comer cohort:\n\n* Subject presents to the emergency department with suspected ACS.\n* Clinical assessments, ECG, and measurements of hs-cTn, single or serial measurement, must be conducted according to ESC guidelines.\n* Collection of WBC data must be performed at initial blood withdrawal after admission to the emergency department.\n* Review board evaluations must confirm the presence or absence of a culprit lesion if coronary angiography was performed, as outlined for the case and control cohorts.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Subject refuses informed consent.\n* Collection of WBC and hs-cTn data is not possible.\n* Criteria for timing of blood sampling for collection of WBC and hs-cTn data cannot be fulfilled.\n* Suspicion of ACS occurs in subjects with no or stable angina pectoris any time between initial blood sampling and start of coronary angiography.",true,"ALL","18 Years",{"count":20,"type":21},3350,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate whether artificial intelligence (AI) algorithms can predict or exclude acute coronary syndrome (ACS) in adults using data generated by routine hematology testing. The main questions the study aims to answer are:\n\n* Can AI algorithms based on white blood cell (WBC) data predict or exclude ACS in subjects with suspected ACS?\n* Can erythrocyte (EC) and\u002For thrombocyte (TC) data, where available, improve or complement WBC-based AI prediction of ACS?\n* How does the diagnostic performance of the AI algorithms compare with high-sensitivity cardiac troponin (hs-cTn), and can the combination of AI algorithms and hs-cTn improve diagnostic performance?\n\nParticipants will undergo clinical assessment and blood testing as part of usual clinical care. Their previously generated clinical information, hematology data, and hs-cTn results will be used to train and test the AI algorithms. Participation in the study does not determine the indication for coronary angiography or treatment, and no additional study-specific treatments are performed.",[25,26,27,28,29],"Acute Coronary Syndrome","Angina Pectoris","NSTEMI - Non-ST Segment Elevation MI","STEMI - ST Elevation Myocardial Infarction","Unstable Angina (UA)",[31,32,33,34,35,36,37],"Artificial Intelligence","AI","hematology analyzer","ACS","white blood cell","Troponin","Machine learning","RECRUITING","2026-06-21",{"date":41,"type":42},"2026-06-24","ACTUAL",{"date":44,"type":42},"2024-02-01",{"date":46,"type":21},"2026-12-31",{"name":48,"class":49},"RobotDreams GmbH","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":50},"100643015","phase-4-reperfusion-approach-in-predicted-in-hospital-delay-for-primary-pci-in-stemi-100643015","NCT07641231","Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI","A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)","RAPID-STEMI","Inclusion Criteria:\n\n* Age equal or greater than 18 years\n* \"Symptom onset-randomization\" time interval \\\u003C12 hours\n* Predicted \"diagnosis-pPCI\" time interval equal or greater than 120 minutes\n* Predicted \"admission-pPCI\" time interval equal or greater than 60 minutes\n* Informed consent received\n\nExclusion Criteria:\n\n* Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and\u002For the inability to evaluate the study primary endpoint",{"count":60,"type":21},240,"INTERVENTIONAL",[63],"PHASE4","This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (\\>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.",[28],[67,68,69,70,71],"in-hospital fibrinolysis","STEMI","pharmacoinvasive strategy","myocardial infarction (MI)","thrombolysis","NOT_YET_RECRUITING","2026-06-08",{"date":75,"type":42},"2026-06-11",{"date":77,"type":21},"2026-05-20",{"date":79,"type":21},"2029-05-20",{"name":81,"class":82},"National Medical Research Center for Cardiology, Ministry of Health of Russian Federation","OTHER_GOV",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":61,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100637367","phase-2-effect-of-guanxinning-tablet-on-coronary-microcirculation-after-primary-percutaneous-coronary-intervention-in-patients-with-acute-myocardial-infarction-100637367","NCT07621107","Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction","A Randomized Explorative Pre-trial of the Effect of Guanxinning Tablet on Coronary Microcirculation After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction","Inclusion Criteria:\n\n* Age between 18 and 80 years (gender is not restricted).\n* STEMI diagnosed for the first time and with an onset time within 12 hours. (According to the \"Chinese Guidelines for the Diagnosis and Treatment of Acute ST - Segment Elevation Myocardial Infarction 2019\" and the fourth - edition \"Global Definition of Myocardial Infarction\" criteria, myocardial infarction refers to acute myocardial injury \\[serum cardiac troponin (cTn) increases and\u002For decreases, and at least once is higher than the upper limit of the normal value (the 99th percentile of the upper limit of the reference value)\\], along with clinical evidence of acute myocardial ischemia, including: (1) Symptoms of acute myocardial ischemia; (2) New ischemic electrocardiogram changes; (3) New pathological Q - wave; (4) New imaging evidence of viable myocardial loss or abnormal wall segmental motion; (5) Coronary artery thrombosis confirmed by coronary angiography, intracavitary imaging examination, or autopsy.)\n* Successfully received PPCI treatment (assessed by visual inspection or quantitative coronary angiography, with residual stenosis of the target lesion \\\u003C 20% after stent implantation or \\\u003C 50% after simple balloon dilation, and forward TIMI blood flow ≥ grade 2).\n* Signed a written informed consent form.\n\nExclusion Criteria:\n\n* Cardiogenic shock with poor response to vasoactive drugs; or uncontrolled acute left - heart failure or pulmonary edema; uncontrolled malignant arrhythmia.\n* LVEF \\\u003C 40%.\n* Currently using nicorandil, other Chinese patent medicines, and Chinese herbal decoctions, etc.\n* Unable to undergo CMR examination for various reasons.\n* Expected to be unable to complete 6 - month treatment with Guanxinning Tablets.\n* Contraindications or allergies to Guanxinning Tablets.\n* Suspected or confirmed hereditary cardiomyopathy (such as hypertrophic, dilated, obstructive cardiomyopathy, cardiac amyloidosis, hemochromatosis cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, etc.).\n* Active or chronic liver disease.\n* Renal insufficiency (eGFR \\\u003C 60ml\u002Fmin\u002F1.73m²).\n* History of previous cerebral hemorrhage.\n* History of alcohol or drug abuse.\n* Known active infection, or severe hematological, metabolic, or endocrine dysfunction.\n* Patients who have received systemic steroid or cyclosporine treatment in the past 3 months.\n* Active malignant tumor.\n* Life expectancy less than 6 months.\n* Pregnant or lactating women.\n* Already participating in other clinical studies.","80 Years",{"count":92,"type":21},70,[94],"PHASE2","①Research objective: In a small sample population, through the pre - experimental method, explore and evaluate the effect of Guanxinning tablets on the coronary microcirculation after primary percutaneous coronary intervention (PPCI) in patients with acute ST - segment elevation myocardial infarction (STEMI), with the change in the percentage of intramyocardial hemorrhage (IMH) in ventricular mass measured by cardiac magnetic resonance (CMR) imaging as the primary endpoint.\n\n②Research significance: The research results of this project will provide preliminary theoretical basis and methodological support for the formal randomized controlled study on evaluating the effect of Guanxinning tablets on the coronary microcirculation after PPCI in STEMI patients. It will offer new ideas for the long - term clinical treatment of STEMI patients after PPCI, and provide important theoretical support for expanding the clinical indications of Guanxinning tablets and exploring the reasons for its improvement of cardiovascular outcomes.",[97,28,68,98,99],"STEMI (ST Elevation MI)","CMD","Coronary Microvascular Dysfunction (CMD)",[101,102,103,104,105],"TCM","traditional chinese medicine","guanxinning tablet","CMR","intramyocardial hemorrhage","2026-05-27",{"date":108,"type":42},"2026-06-02",{"date":110,"type":21},"2026-06-01",{"date":112,"type":21},"2027-02-01",{"name":114,"class":115},"Beijing Anzhen Hospital","OTHER",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":61,"phases":125,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":50},"100639617","the-core---fr-clinical-trial-100639617","NCT07598565","The CORE - μFR Clinical Trial","μFR -Guided Complete Revascularization in Patients With Acute Coronary Syndromes","Inclusion Criteria:\n\n1. Patients presenting with ACS within 72 hours of successful culprit PCI\n2. Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics:\n\n   1. at least 50% diameter stenosis by visual assessment\n   2. a vessel diameter of at least 2.5 mm\n   3. amenable to successful PCI\n\nExclusion Criteria:\n\n1. Cardiogenic shock or severe heart failure (NYHA class ≥III)\n2. Severely impaired renal function: creatinine \\>2 mg\u002Fdl or estimated glomerular filtration rate (eGFR) \\\u003C30 ml\u002Fmin\u002F1,73 m²\n3. Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated\n4. Pregnancy or intention to become pregnant during the trial\n5. Life expectancy less than one year\n6. Ambiguity in the identification of the culprit vessel\u002Flesion\n7. Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and\u002For Tako-Tsubo Syndrome\n8. Any ambiguity in the diagnosis of ACS\n9. Inability to provide informed consent\n10. Patients with only one coronary artery lesion with diameter stenosis \\>90% and\u002For TIMI flow \\\u003C3\n11. Patients in whom the NCV is treated at the time of the index procedure\n12. An interrogated lesion is at the site of a myocardial bridge\n13. An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction\n14. An interrogated lesion is in a bypass graft\n15. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification\n16. Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement",{"count":124,"type":21},350,[126],"NA","Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients.\n\nThe Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI.\n\nPatients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is \\>0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.",[129,130,28,131],"Acute Coronary Syndromes (ACS)","NSTEMI - Non-ST-Segment Elevation Myocardial Infarction","Multivessel Coronary Artery Disease",[133,134,135],"Murray-law based Quantitative Flow Ratio (μFR)","Non culprit vessel","Revascularization","2026-05-19",{"date":138,"type":42},"2026-05-22",{"date":140,"type":21},"2026-05-18",{"date":142,"type":21},"2028-06-30",{"name":144,"class":115},"University of Roma La Sapienza",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":152,"targetDuration":4,"studyType":61,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":50},"100640995","safety-and-feasibility-of-transcatheter-injectable-hydrogel-in-acute-stemi-reperfusion-injury-refine-study-100640995","NCT07601997","Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study)","Clinical Application Study on the Safety and Feasibility of Transcatheter Injectable Protein Alginate-based Hydrogel for Alleviating Reperfusion Injury in Acute STEMI","Inclusion Criteria:\n\n1. Aged 18 to 80 years;\n2. Diagnosed with first-onset acute anterior wall ST-segment elevation myocardial infarction (STEMI), requiring primary percutaneous coronary intervention (PCI) and stent implantation;\n3. Ischemic symptoms (e.g., chest pain, precordial discomfort) persist for \\>30 minutes, and electrocardiographic findings meet the following criteria: ST-segment (J-point) elevation ≥1.0 mm (i.e., amplitude 0.1 mV) in all conventional leads except leads V2 and V3. For leads V2 and V3, the ST-segment elevation criteria are: ≥2.5 mm in males \\\u003C40 years old, ≥2.0 mm in males ≥40 years old, and ≥1.5 mm in females of all ages;\n4. The time interval from the onset of ischemic symptoms to the first PCI balloon dilation is ≤12 hours;\n5. Admission coronary angiography shows that the left anterior descending artery (LAD) has a TIMI flow grade of 0 (complete occlusion), and the TIMI flow grade reaches 3 after stent implantation;\n6. Able to understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form personally or via a legal representative, and be willing to complete the follow-up in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n1. Complicated with cardiogenic shock or cardiac arrest; or complicated with acute myocardial infarction mechanical complications requiring surgical or interventional intervention (e.g., ventricular septal perforation, papillary muscle rupture, free wall rupture), or complicated with giant left ventricular aneurysm;\n2. Previously diagnosed with hypertrophic cardiomyopathy, hemodynamically significant congenital heart disease, severe valvular heart disease, chronic cor pulmonale, chronic heart failure, or with a history of cardiac tamponade, pericarditis, or myocarditis;\n3. History of previous myocardial infarction, coronary intervention (PCI), or coronary artery bypass grafting (CABG);\n4. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months;\n5. Heart failure severity at admission reaches Killip classification Grade III or above;\n6. Complicated with malignant arrhythmia, complete atrioventricular block, or new-onset complete left bundle branch block (LBBB);\n7. Diagnosed or suspected aortic dissection;\n8. Diabetes mellitus with severe complications;\n9. Complicated with atrial fibrillation and receiving only warfarin treatment, or with a high bleeding risk;\n10. Received thrombolytic therapy prior to PCI;\n11. Diameter of the infarct-related artery \\\u003C 2 mm or abundant coronary collateral circulation in the risk area;\n12. Coronary angiography indicates diffuse vascular lesions or severe calcification that may affect the absorption of protein alginate-based hydrogel;\n13. Severe complications (e.g., coronary artery rupture, perforation, or stent dislodgement) occurring during PCI;\n14. Received coronary bioresorbable stent implantation;\n15. Complicated with severe acute infection requiring systemic treatment;\n16. Currently diagnosed with malignant tumor or receiving malignant tumor treatment;\n17. Severe autoimmune disease requiring therapeutic intervention;\n18. History of severe anemia (hemoglobin \\\u003C 60 g\u002FL) or thrombocytopenia (platelet count \\\u003C 100×10⁹\u002FL);\n19. Known renal insufficiency (including estimated creatinine clearance \\\u003C 30 ml\u002Fmin\u002F1.73 m², or receiving treatment for severe renal insufficiency);\n20. Alanine aminotransferase (ALT) level exceeding 3 times the upper limit of normal, with the investigator judging clinically significant liver dysfunction;\n21. Known allergy to the study product or any radiocontrast agent;\n22. Contraindications to cardiovascular magnetic resonance (CMR) examination (e.g., implanted cardiac pacemaker, implantable cardioverter-defibrillator, nerve stimulator, cerebral aneurysm clip, cochlear implant, or claustrophobia);\n23. Cognitive dysfunction, dementia, or severe mental illness;\n24. Currently participating in other clinical trials and have not yet reached the primary endpoint;\n25. Expected survival period \\\u003C 1 year due to comorbidities;\n26. Pregnant or lactating women, or fertile subjects who do not take effective medical contraceptive measures during the study period;\n27. Other factors that the investigator deems may have a significant impact on result judgment or the safety and efficacy of the subjects.",{"count":153,"type":21},20,[126],"The purpose of this clinical trial is to preliminarily evaluate the safety and feasibility of the transcatheter injectable protein alginate-based hydrogel developed and manufactured by Myomed Technology (Shaoxing) Co., Ltd. in alleviating reperfusion injury in acute STEMI. This is a randomized controlled trial with a blank control group (conventional PCI treatment). A total of 20 patients will be enrolled in a 1:1 ratio into the test group and the control group.",[28],"2026-05-15",{"date":138,"type":42},{"date":160,"type":21},"2026-05-30",{"date":162,"type":21},"2027-04-30",{"name":164,"class":49},"Myomed Technology (Shaoxing) Co., Ltd.",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":172,"targetDuration":174,"studyType":22,"phases":4,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100549767","supersaturated-oxygen-comprehensive-observational-registry-100549767","NCT06438315","SuperSaturated Oxygen Comprehensive Observational Registry","SSCORE","Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label) Cohorts must meet ALL the following baseline criteria:\n\nPatients must be ≥ 18 years and ≤ 80 years of age\n\nPresentation with AMI and successful revascularization of the infarct-related artery with PCI\n\nThe subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)\n\nTreatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study.\n\nSubjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria:\n\nThe primary culprit lesion must be in the left anterior descending (LAD) coronary artery\n\nSuccessful primary PCI within 6 hours of symptom onset (defined as persistent symptoms that caused the patient to pursue medical care), as documented by \\\u003C50% diameter residual angiographic stenosis and Thrombolysis In Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel\n\nNo major complications such as presence of post-PCI dissection or perforation, serious bleeding, presence of cardiogenic shock (including the use of intra-aortic balloon pump (IABP) or mechanical circulatory support (MCS)) before the end of PCI procedure\n\nNot pregnant or nursing\n\nExclusion Criteria\n\nSubjects will be excluded if they meet any of the following criteria:\n\nLife expectancy of less than 2 years\n\nNo access to medical records from either the index hospitalization or subsequent outpatient visits\n\nCurrently participating in an interventional drug or device trial\n\ncMRI Sub-Study\n\nAt qualifying sites that can perform cMRI scans, subjects who meet the following inclusion and exclusion criteria will be considered for the cMRI sub-study.\n\ncMRI Inclusion Criteria\n\nSubjects will be included in the cMRI sub-study must meet all these criteria:\n\nMeet all the inclusion and exclusion criteria for the overall study\n\nConsent during index hospitalization to participate in the main study\n\ncMRI Exclusion Criteria\n\nSubjects will be excluded from the sub-study if they are contraindicated to MRI, including any of the following:\n\nNon-MRI compatible cardiac pacemaker or implantable defibrillator; Non-MRI compatible aneurysm clip or other metallic implants; Neural Stimulator (i.e., TENS unit); Any implanted or magnetically activated device (insulin pump); Any type of non-MRI compatible ear implant; Metal shavings in the orbits; Any indwelling metallic foreign body, shrapnel, or bullet; Any condition contraindicating MRI, including claustrophobia; Inability to follow breath-hold instructions or to maintain a breath-hold for \\>15 seconds; and Known hypersensitivity or contraindication to gadolinium contrast.",{"count":173,"type":21},1000,"2 Years","The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility, infarct size reduction, and cost-effectiveness of SSO2 Therapy versus PCI alone among patients with anterior AMI in routine clinical practice.",[28,177],"AMI","2026-05-12",{"date":157,"type":42},{"date":181,"type":42},"2024-08-13",{"date":183,"type":21},"2029-03-31",{"name":185,"class":49},"TherOx",25,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":61,"phases":196,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100629694","phase-3-prehospital-pulse-dose-glucocorticoid-in-patients-with-st-segment-elevation-myocardial-infarction-2---the-pulse-mi-2-trial-100629694","NCT07478003","Prehospital Pulse-dose Glucocorticoid in Patients With ST-segment Elevation Myocardial Infarction 2 - The PULSE-MI 2 Trial","PULSE-MI 2","Inclusion Criteria:\n\n* Age ≥18 years including fertile women\n* Acute onset of chest pain with \\\u003C 24 hours duration\n* STEMI as characterized on electrocardiogram (ECG) by one of the following:\n\n  1. at least two contiguous leads with ST-segment elevation ≥2.5 mm in men \\\u003C 40 years, ≥2 mm in men ≥40 years, or ≥1.5 mm in women in leads V2-V3 and\u002For ≥1 mm in the other leads,\n  2. presumed new left bundle branch block with ≥1 mm concordant ST-segment elevation in leads with a positive QRS complex, or concordant ST-segment depression ≥1 mm in V1-V3, or discordant ST-segment elevation ≥5 mm in leads with a negative QRS complex\n  3. Isolated ST depression ≥0.5 mm in leads V1-V3 indicating posterior acute myocardial infarction (AMI)\n  4. ST-segment depression ≥1 mm in eight or more surface leads, coupled with ST-segment elevation in aVR and\u002For V1 suggesting left main-, or left main equivalent- coronary obstruction\n\nExclusion Criteria:\n\n* Suspected other type I acute myocardial infarction at time of potential randomization\n* Initial presentation with cardiac arrest (out of hospital cardiac arrest)\n* Known allergy to glucocorticoid",{"count":195,"type":21},5204,[197],"PHASE3","BACKGROUND Myocardial reperfusion with the use of primary percutaneous coronary intervention (PCI) including stent implantation is the most efficacious treatment for patients with (STEMI) and improves prognosis significantly. Due to continuous improvements in the treatment, the mortality for patients with STEMI has decreased dramatically, but despite these improvements, the mortality rate seems to have reached a plateau at around 10% within 1 year. In addition, 10% develop clinical heart failure with a per se 50% mortality rate within 5 years. Moreover, congestive heart failure is associated with a highly impaired quality of life due to fatigue dyspnea and reduced exercise capacity. Thus, there is a need for further improvement in the treatment to drive the event rates further down. One such key target is reducing the damage to the heart muscle (infarct size) to preserve the heart function and prevent mortality and heart failure. One major driver of infarct size and mortality is reperfusion injury which may account for up to 50% of the damaged myocardium. Reperfusion injury occurs within the first minutes to hours after the restoration of the blood flow in the occluded artery and reperfusion therapy can therefore be considered a \"double-edged sword\", since the ischemic injury may additionally be worsened by reperfusion injury. However, the phenomenon of reperfusion injury is not completely understood, and no preventive treatments exist. Multiple pathophysiological factors may contribute to reperfusion injury of which inflammation has been described as a key factor.\n\nInflammation is induced immediately after the onset of acute myocardial ischemia and is subsequently exacerbated following reperfusion. Hence, inflammation per se may drive excessive cardiomyocyte death resulting in decreased contractility and increased infarct size post-STEMI. Moreover, in the course following STEMI and subsequently reperfusion, the myocardium starts healing and scarring resulting in remodelling of the ventricle potentially causing either compensatory hypertrophy or thinning of the myocardium, which may lead to reduced left ventricle ejection fraction (LVEF) and heart failure. Of note, inflammation plays a critical role in ventricular remodeling post-AMI, thus inflammation in relation to reperfusion injury may extend myocardial damage following STEMI.\n\nGlucocorticoids are crucial in the regulation of the systemic inflammatory response and may therefore be beneficial in limiting myocardial injury following STEMI. We previously conducted the phase II randomized, placebo-controlled PULSE-MI trial (Nov 2022-Oct 2023) in 742 prehospital STEMI patients, showing pulse-dose glucocorticoid was safe and improved LVEF, infarct size, and microvascular obstruction, with a trend toward lower 3-month mortality. However, as the trial was not powered for clinical outcomes, it remains unproven whether this treatment reduces post-STEMI mortality. Thus, the aim of this prospective, randomized trial is to evaluate the effect of prehospital pulse-dose glucocorticoid on all-cause mortality in patients with STEMI.\n\nTo reduce the degree of inflammation effectively and adequately, intervention is to be made as soon as possible as close to initiation of ischemia, as recognized from patients' symptom debut, and before revascularization with primary PCI in the prehospital setting since the effect is more pronounced if the treatment is initiated early after the onset of STEMI. In addition to reperfusion induced inflammation, ischemia itself, immediately after occlusion of the artery, induces inflammation. Hence, initiation of the intervention in the ambulance is needed to harvest the potentially beneficial effects of pulse glucocorticoid therapy as soon as possible. Thus, by performing intervention in the pre-hospital setting, the investigators expect that participation in the trial will have the potential to produce a direct clinically relevant benefit for the patient resulting in reduced all-cause mortality in patients with STEMI.\n\nHYPOTHESIS In patients with STEMI undergoing primary PCI, 250 mg methylprednisolone administrated in the pre-hospital setting reduces all-cause mortality.\n\nSAMPLE SIZE The primary endpoint is all-cause mortality one year after the last patient has been included. The median follow-up of the trial is expected to be 3 years and minimum follow-up of 1 year. As an estimate based on findings from the PULSE-MI trial and the DANAMI-3 trial, the estimated event rate of in the placebo arm is 9% during follow-up. Glucocorticoid is expected to reduce all-cause mortality corresponding to a hazard ratio of 0.77. To demonstrate the reduction in the primary outcome with an 80% power at a 5% significance level, 2602 patients in each treatment arm is needed, thus 5204 patients in total. The primary analyses will be intention to treat principle",[28],[68,201,202],"Prehospital Intervention","Glucocorticoids","2026-04-20",{"date":205,"type":42},"2026-04-23",{"date":203,"type":42},{"date":208,"type":21},"2036-04-01",{"name":210,"class":115},"Thomas Engstrom",4,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":220,"targetDuration":4,"studyType":61,"phases":222,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":50},"100632251","phase-4-multicenter-trial-of-antithrombotic-strategies-in-acute-coronary-syndrome-with-coronary-artery-ectasia-100632251","NCT07511257","Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia","Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: A Multicenter Randomized Clinical Trial","OVER-TIME II","Inclusion Criteria:\n\n* Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.\n* Recent ACS within 7 days prior to enrollment, defined by all of the following:\n* Clinical presentation consistent with acute coronary syndrome.\n* Elevated high-sensitivity cardiac troponin above the 99th percentile.\n* Presence or absence of persistent ST-segment elevation.\n* Coronary artery ectasia in the culprit coronary artery, defined by all of the following:\n* The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA).\n* Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow.\n* Hospital admission lasting more than 24 hours.\n* Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted.\n* Ability and willingness to provide written informed consent and to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.\n* Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \\[eGFR\\] \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² at hospital discharge.\n* History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding.\n* Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \\\u003C30% plus at least one of the following:\n* More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or\n* NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.",{"count":221,"type":21},326,[63],"Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain.\n\nDual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy.\n\nThe OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.",[225,129,28,226],"Coronary Artery Ectasia","NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)",[225,25,228,229],"Anticoagulation","Dual Antiplatelet Therapy","2026-04-06",{"date":232,"type":42},"2026-04-09",{"date":234,"type":42},"2026-02-11",{"date":236,"type":21},"2029-06",{"name":238,"class":115},"Instituto Nacional de Cardiologia Ignacio Chavez",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":61,"phases":248,"briefSummary":249,"conditions":250,"keywords":251,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":261,"locationsCount":50},"100627215","phase-3-use-of-the-methoxyflurane-as-pain-killer-in-the-prehospital-management-of-acute-myocardial-infarction-100627215","NCT07445737","Use of the Methoxyflurane as Pain-killer in the Prehospital Management of Acute Myocardial Infarction","MAMI","Inclusion Criteria:\n\n* Patient age ≥ 18 years\n* Patient managed in pre-hospital setting for a ST elevation myocardial infarction (STEMI) : Chest pain \\\u003C 12 hours with moderate to severe pain (VAS \\> 6\u002F10) or STEMI on ECG according to 2017 ESC guidelines\n\nExclusion Criteria:\n\n* Previous analgesic treatment for this episode of chest pain\n* Hypersensitivity to morphine, methoxyflurane, any fluorinated anesthetic or any of the excipients listed in SmPC,\n* Decompensated respiratory failure (in the absence of artificial ventilation),\n* Severe hepatocellular insufficiency (with encephalopathy),\n* Acute head trauma and intracranial hypertension in the absence of controlled ventilation,\n* Uncontrolled epilepsy,\n* Treatment with buprenorphine, nalbuphine and pentazocine, naltrexone, nalmefene or sodium oxybate,\n* Breastfeeding, in case of initiation or continuation after birth of a long-term treatment.\n* Known malignant hyperthermia or genetic predisposition of the patient.\n* History of serious adverse effects of the patient or his family after administration of inhaled anesthetics.\n* History of signs of liver damage after use of methoxyflurane or after anesthesia with a halogenated hydrocarbon.\n* Clinically significant renal impairment.\n* Known renal failure with creatinine clearance below 30 ml\u002Fmin or undergoing extracorporeal renal replacement therapy.\n* Altered level of consciousness due to any cause, including head trauma, drug or alcohol use.\n* Clinical evidence of cardiovascular instability (PAS \\\u003C90 mm Hg).\n* Clinical evidence of respiratory depression.\n* Incapacity to self-assess pain intensity\n* Incapacity to methoxyflurane self-administration\n* Known pregnancy, breastfeeding, minors or incapacity (curatorship or guardianship)\n* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants\n* Absence of a Social Security",{"count":247,"type":21},700,[197],"* Chest pain is the main symptom of acute myocardial infarction. A precocious analgesic treatment is justified by patient's comfort and unfavorable hemodynamic consequences of persistent pain. Morphine is the painkiller historically prescribed in this situation. Morphine has never been evaluated vs placebo and is strongly suspected to decrease oral anti-platelet efficacy. Then, morphine has been downgraded, in the 2017 European guidelines (European Society of Cardiology - ESC) from I to IIa. To find alternative treatment is required.\n* The methoxyflurane is an anesthetic gas used in emergency setting for about twenty years. It is now commonly used in France. Its analgesic properties have been demonstrated. Its main advantages are its maneuverability as it is delivered by inhalation, i.e. without (before) any venous access and self-administered by the patient. Tolerability is good. It could be an excellent alternative to morphine.",[28],[252,253,254],"chest pain","morphine","methoxyflurane","2026-02-25",{"date":257,"type":42},"2026-03-03",{"date":259,"type":21},"2026-06",{"date":236,"type":21},{"name":262,"class":115},"Assistance Publique - Hôpitaux de Paris",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":270,"targetDuration":4,"studyType":61,"phases":272,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":50},"100622210","phase-1-safety-and-efficacy-of-fap-icdc-in-acute-myocardial-infarction-with-cardiogenic-shock-100622210","NCT07380659","Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock","Safety and Efficacy of Allogeneic Immunosuppressive CAR-DC Targeting FAP in the Treatment of Acute Myocardial Infarction With Cardiogenic Shock","Inclusion Criteria（patients）:\n\n* Age ≥ 18 years and \\\u003C 80 years.\n* Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:\n\n  1. Post-emergent revascularization (PCI or CABG)\n  2. Systolic blood pressure \\\u003C 90 mmHg for \\>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \\>90 mmHg\n  3. Signs of impaired organ perfusion, meeting at least one of the following criteria:\n\n     1. Altered mental status\n     2. Cold, clammy skin and extremities\n     3. Oliguria, with urine output \\\u003C30 mL\u002Fh\n     4. Arterial lactate level \\>2 mmol\u002FL\n* The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.\n\nExclusion Criteria（patients）:\n\n1. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).\n2. Cardiac arrest.\n3. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).\n4. Shock due to other causes (e.g., sepsis, hypovolemia).\n5. Resuscitation duration \\>30 minutes.\n6. Absence of spontaneous cardiac activity.\n7. Persistent electrical instability.\n8. Active bleeding or contraindications to heparin use.\n9. Active autoimmune disease requiring immunosuppressive therapy.\n10. History of malignancy.\n11. Infection, including:\n\n    * Active hepatitis B (HBV DNA \\>1000 copies\u002FmL by PCR), hepatitis C, syphilis, or HIV infection at screening.\n    * Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.\n12. Pregnant women.\n13. Contraindications to the investigational drug or study procedures.\n\nInclusion Criteria（donors）:\n\n* Age ≥ 18 years and ≤ 75 years.\n* Has provided written informed consent.\n* Hematocrit \\>30%, lymphocyte count \\>0.5 × 10\\^9\u002FL, platelet count \\>60 × 10\\^9\u002FL.\n* Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.\n\nExclusion Criteria（donors）:\n\n* Active infection requiring treatment.\n* History of malignancy.\n* Active autoimmune disease requiring immunosuppressive therapy.",{"count":271,"type":21},18,[273],"PHASE1","To study the safety and efficacy of fibroblast activation protein (FAP)-targeted allogeneic immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of acute myocardial infarction with cardiogenic shock and provide a new method for the treatment of acute myocardial infarction with cardiogenic shock.",[276,277,28],"Cardiogenic Shock","Cardiogenic Shock Post Myocardial Infarction",[279],"acute myocardial infarction with cardiogenic shock","2026-01-28",{"date":282,"type":42},"2026-02-02",{"date":284,"type":21},"2026-01-20",{"date":286,"type":21},"2027-02-28",{"name":288,"class":115},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":50},"100617793","hong-kong-cardiogenic-shock-initiative-100617793","NCT07323238","Hong Kong Cardiogenic Shock Initiative","HK CSI","Inclusion Criteria:\n\n* Diagnosis of acute myocardial infarction (AMI) with the ECG and\u002For biomarker evidence of S-T elevation myocardial infarction (STEMI) or non -S-T elevation myocardial infarction (NSTEMI)\n* Cardiogenic Shock is defined as presence of at least two of the following\n\n  1. Hypotension (systolic blood pressure ≤ 100 mmHg, or inotropes\u002Fvasopressors to maintain systolic blood pressure ≥ 100 mmHg)\n  2. Evidence of end organ perfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria\u002Fanuria\n  3. Hemodynamic criteria represented by cardiac index of \\\u003C2.2 L\u002Fmin\u002Fm² or a cardiac ≤ 0.6 watts\n* Patient is supported with a transvalvular MCS as the initial device (criteria for GCSI-eligible Cohort)\n* Patients undergo PCI within 12 hours of hospital presentation (criteria for GCSI-eligible Cohort)\n* Subject or legally designated representative (LDR) has provided written informed consent. For patients not able to provide consent, data collection will be conducted in retrospective manner with study consent waived.\n\nExclusion Criteria:\n\n* Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 20 minutes\n* Patients demonstrate any signs of anoxic brain injury prior to the INDEX PCI (signs of anoxic injury include, posturing, seizures).\n* IABP placed prior to MCS (criteria for GCSI-eligible Cohort)\n* Septic, anaphylactic, hemorrhagic, and neurologic causes of shock\n* Non-ischemic causes of shock\u002Fhypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)\n* Active bleeding for which MCS in contraindicated\n* Recent major surgery for which MCS is contraindicated\n* Mechanical complication of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)\n* Known left ventricular thrombus for which MCS in contraindicated (criteria for GCSI-eligible Cohort)\n* Mechanical aortic prosthetic valve (criteria for GCSI-eligible Cohort)\n* Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.\n\nPatients who fulfills all Eligibility Criteria would be recruited and considered GSCI-eligible. AMI-CS patients that did not use MCS, ie. Not fulfiliing both Inclusion Criteria 3, 4, would not be considered screen failure and would still be screened and recruited into HKCSI GCSI-ineligible cohort. Likewise, patients who meet any of Exclusion Criteria will not be GCSI-eligible. Specifically, patients who met exclusion criteria 3, 9, 10 only will be recruited into GCSI-ineligible cohort.",{"count":297,"type":21},320,"Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes. Observational studies like the National Cardiogenic Shock Initiative (NCSI), Inova-Shock registry, and J-PVAD (Japan registry for percutaneous ventricular assist device) registry emphasize the importance of structured care systems when using mechanical circulatory support (MCS).\n\nFollowing the release of the Danger Shock trial, MCS use is expected to rise. Hospitals will need to monitor practices and work with payers to ensure coverage. Using regional real-world data can assist this process, making the collection and analysis of MCS outcomes essential.\n\nThe NCSI (NCT03677180) aimed to evaluate outcomes with a protocolized approach prioritizing rapid diagnosis, timely MCS delivery, and invasive hemodynamic monitoring via pulmonary artery (PA) catheters. The study involved 406 patients from 2016 to 2020, with an average age of 64 years. Most (67%) had shock, with 85% on vasoactive drugs. Witnessed outof-hospital cardiac arrest occurred in 17%, and in-hospital arrest in 30%. During MCS implantation, 9% were actively resuscitating. Patients mostly in SCAI stage C\u002FD (73%) and stage E (27%) presented with low blood pressure, high lactate, and reduced cardiac power output. About 70% received MCS before PCI, with 90% using PA catheters. Most had STEMI, with median door-to-support and door-to-balloon times of about 78 and 81 minutes. Survival rates were high: 99% procedural, 79% to discharge, 77% at 30 days, and 62% at one year for stage C\u002FD shock. Patients with stage E shock had lower survival. Early use of MCS improved hemodynamics and survival. Further research, like the CERAMICS (Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock) study, aims to refine escalation strategies. The Danger Shock trial highlighted the importance of minimizing complications such as bleeding, limb ischemia, haemolysis, and kidney injury.\n\nCurrently in Hong Kong, prevalence of CS among AMI patients is 5-10%, in-line with global statistics. Among which, 30-day and 1-year mortality of AMI-CS patients in Hong Kong was reported at 29% and 39.5% respectively. Although the use of MCS has been shown in the above overseas studies to improved survival rates of AMI-CS patients, the utilisation rate of MCS among AMI-CS patients in Hong Kong was reported at 36.5% in a previous single-centre study, limited by an array of factors including limited device availability, allocations of resources and patient selection strategy, lack of region-specific evidence and device affordability. Global Cardiogenic Shock Initiative (GCSI) is an ongoing international multicenter registry involving centers from USA, Germany, and Hong Kong, and focus on the outcomes of AMI-CS patients received Impella support. The GCSI is expanding to many other regions. In the Hong Kong Cardiogenic Shock Initiative (HK-CGSI) study we aim to include sites with experience in MCS, all of whom have the capability of MCS escalation and evaluate outcomes across these centers.\n\nThe goal is not only to capture the effects of previously established best practices but gain insights into regional best practices, and together with data from the global cardiogenic shock initiative (GCSI), to better establish the adoption of novel best practices and their effect on complication rates.\n\nIn parallel to GCSI-eligible cohort, i.e. Impella used as the first supporting device for patients with AMI-CS, given the significant portion of patients who could not receive MCS under current limitations in Hong Kong, in the HK-CSI, we will include also the GCSI-ineligible cohort, i.e. AMI-CSI without using Impella or not as the first MCS used, to understand the full picture of clinical outcomes of AMI-CS patients of Hong Kong.\n\nThe HK-CSI study is an observational registry solely and not a treatment study. This single-arm registry captures data generated during procedures which are considered standard of care. Participation in this registry will be performed with waiver of consent of the patient and will have no influence on the type and extent of treatment.",[300,28,276,277,301],"Cardiogenic Shock Acute","Mechanical Circulatory Support","2026-01-07",{"date":304,"type":42},"2026-01-09",{"date":306,"type":21},"2026-04-01",{"date":308,"type":21},"2030-10-02",{"name":310,"class":115},"Prince of Wales Hospital, Shatin, Hong Kong",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":61,"phases":321,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":333,"leadSponsor":335,"locationsCount":50},"100615821","phase-3-epicardial-cardiac-fat-ct-epic-ct-100615821","NCT07297589","Epicardial Cardiac Fat-CT (EPIC-CT)","Epicardial Cardiac Fat Comparative Trial","EPIC-CT","Inclusion Criteria:\n\n* Criteria for the fourth definition of acute myocardial infarction with and without ST-segment elevation.\n\n  * Diagnosed with type 2 diabetes.\n  * Initial serum high-sensitivity CRP value \\> 2.0 mg\u002FL.\n  * Clinically obese.\n  * LVEF \\>50%.\n\nExclusion Criteria:\n\n* Patients who have recently received immunosuppressive therapy\n* Patients with a history of ischemic heart disease\n* Known allergy to any of the medications used\n* Use of any of the study drugs more than 6 months prior to randomization\n* Patients experiencing diabetic ketoacidosis\n* Patients with hemodynamic instability (mean arterial pressure \\\u003C60 mmHg while on vasopressors)\n* Pregnant women\n* Patients with a history or current diagnosis of cancer\n* Patients with documented active infections, such as pneumonia or urinary tract infections\n* Patients with pancreatitis",{"count":320,"type":21},136,[197],"Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an increase in visceral fat. Among these, the role of epicardial fat volume in the presence of atheromatous plaques in patients with coronary artery disease has been emphasized, along with the link between its volume and the risk of ischemic cardiovascular events. Consequently, recent decades have seen focused research on the potential of epicardial fat as a marker for major adverse cardiac events and on strategies to reduce its volume as a treatment goal for patients with risk factors.\n\nSelective sodium-glucose cotransporter 2 inhibitors are drugs that, beyond their antihyperglycemic effect, have demonstrated cardiovascular benefits through various mechanisms, including a reduction in epicardial fat. This was supported by a previous study conducted by our research group, although no statistically significant difference was found. On the other hand, GLP-1 agonists are effective drugs for weight control in patients with severe obesity. However, little research has been done on their effect on more localized fat, such as epicardial fat.",[28,324],"Epicardial Fat",[326,68,327,328],"Epicardial fat","Semaglutide","Dapagliflozin","2025-12-30",{"date":331,"type":42},"2026-01-02",{"date":329,"type":42},{"date":334,"type":21},"2027-03",{"name":336,"class":82},"Instituto Mexicano del Seguro Social",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":61,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100615291","phase-4-intensive-cholesterol-lowering-within-24-hours-of-pci-perioperative-period-100615291","NCT07290699","Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period","INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial","INCLINE-AMI","Inclusion Criteria:\n\n* Age ≥18 years;\n* Meet the definition of acute myocardial infarction according to the \"2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction\", including STEMI and NSTEMI with onset \\\u003C24 hours;\n* Able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Severe mental disorders that prevent the expression of consent;\n* Severe heart failure (Killip class III or IV) or cardiogenic shock;\n* According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;\n* Investigator's judgment that the subject cannot complete long-term follow-up;\n* Intolerance to statins or cholesterol absorption inhibitors;\n* Intolerance to injections;\n* Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;\n* Pregnant women.",{"count":346,"type":21},2442,[63],"This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \\\u003C24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.",[28,226],[351,352,353],"Acute myocardial infarction","Recaticimab","PCSK9 inhibitor","2025-12-16",{"date":356,"type":42},"2025-12-18",{"date":358,"type":21},"2026-01-01",{"date":360,"type":21},"2028-08-30",{"name":362,"class":115},"Second Affiliated Hospital of Nanchang University",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":371,"targetDuration":4,"studyType":61,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":50},"100605282","early-thrombolysis-guided-by-ai-assisted-app-in-patients-with-stemi-100605282","NCT07160491","Early Thrombolysis Guided by AI-Assisted App in Patients With STEMI","Early Pre-hospital Thrombolysis Guided by Artificial Intelligence Assisted Mobile Application in Patients With ST-elevation Myocardial Infarction: A Multi-center Cluster Randomized Controlled Trial","EARLY-OPEN","Inclusion Criteria:\n\n* (the following inclusion conditions shall be met at the same time):\n\n  1. age: ≥ 18 years and ≤ 80 years;\n  2. Chest pain lasted for more than 30 min, and the onset time of chest pain was ≤ 12 hours;\n  3. ECG: ST segment elevation after J-point in 2 or more adjacent leads: limb leads ≥ 0.1 mv or chest leads ≥ 0.2 mv;\n  4. it is expected that \"guide wire passing through the lesion\" could not be achieved within 120 min after the diagnosis of STEMI;\n  5. Signed informed consent .\n\nExclusion Criteria:\n\n* (1) Cardiac rupture; (2) Complete left bundle branch block (LBBB) or ventricular pacing; (3) There are contraindications to thrombolysis; (4) Have serious comorbidities; (5) Have complex heart disease; (6) There are situations that are not suitable for clinical trials.",{"count":372,"type":21},3356,[126],"The aim of the study is to elucidate whether guiding by a novel artificial intelligence assisted mobile application can improve the clinical outcomes of patients in whom \"guide wire passing through the lesion\" could not be achieved within 120 min after diagnosis of STEMI, compared to conventional treatment strategies. With concerns of the inadequate use of thrombolysis in patients with STEMI in China, this study applies a new artificial intelligence assisted mobile application to guide the process of thrombolysis combined with PCI treatment, in order to accomplish the rapid coordination and cooperation of the whole medical network during re-perfusion treatment in different regions and different medical institutions in China, increases the proportion of early thrombolysis in pre-hospital setting, shortens the time from STEMI onset to reperfusion, and provides a reliable, effective and replicable new strategy for promoting and optimizing early reperfusion.",[28],[377,378,379,380],"Thrombolysis","appliaction","myocardial infarction","cluster randomized trial","2025-09-14",{"date":383,"type":42},"2025-09-18",{"date":385,"type":42},"2025-09-08",{"date":387,"type":21},"2029-07-31",{"name":389,"class":115},"Shenyang Northern Hospital",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":61,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":4},"100585992","microvascular-obstruction-diagnosis-using-the-cofi-system-assessment---ii-100585992","NCT06909578","Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II","MOCA II","Inclusion Criteria:\n\n* Clinical:\n\n  1. Subject ≥18 years of age\n  2. Ability to provide written informed consent according to GCP and governing regulations\n  3. Diagnosis of acute anterior STEMI\n  4. Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.\n\nPPCI \\& Angiographic\n\n1. Culprit lesion in the LAD\n2. COFI ballon can be placed according to IFU\n3. Required stent diameter ≥ 2.75 mm and ≤ 5mm\n4. Required stent length ≥ 15 mm\n5. Successful PPCI Procedure as documented by \\\u003C50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.\n\nExclusion Criteria:\n\n* Clinical:\n\n  1. Cardiogenic shock\n  2. Thrombolytic therapy administered for this STEMI\n  3. Contraindication to CMRI\n\n     1. Cardiac pacemaker or implantable defibrillator;\n     2. Non-MRI compatible aneurysm clip;\n     3. Neural Stimulator (i.e., TENS unit);\n     4. Any implanted or magnetically activated device (insulin pump);\n     5. Any type of non-MRI compatible ear implant;\n     6. Metal shavings in the orbits;\n     7. Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;\n     8. Any history indicating contraindication to MRI\n     9. Inability to follow breath hold instructions or to maintain a breath hold for \\>15 seconds; and\n     10. Known hypersensitivity or contraindication to gadolinium contrast.\n  4. Subject with previous MI and\u002For known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease\n  5. Major bleeding ≤ 30d prior to intervention\n  6. Major surgery ≤ 30d prior to intervention\n  7. TIA or stroke ≤ 30d prior to intervention\n  8. Heart failure with inotrope support and\u002For consideration for LVAD or heart transplant\n  9. Known severe renal disease with creatinine \\> 2.5 mg\u002FdL and\u002For eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n  10. Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the CIP, confound the data interpretation, or is associated with limited life expectancy of less than one year\n  11. Current participation in another clinical study\n  12. Pregnancy\n\nPPCI \\& Angiographic:\n\n1. CABG of LAD\n2. Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate\u002Fheavy calcification)\n3. Cardiac condition preventing the use of the CoFI System\n4. Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb\u002FIIIa inhibitors or adenosine\n5. Cardiac condition mandating elective PCI\u002FCABG procedure prior to CMRI",{"count":398,"type":21},200,[126],"A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations.\n\nEach study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.",[402,28],"Microvascular Obstruction (MVO)","2025-07-07",{"date":405,"type":42},"2025-07-10",{"date":407,"type":21},"2025-09-01",{"date":409,"type":21},"2026-12-01",{"name":411,"class":49},"CorFlow Therapeutics AG",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100565444","correlation-between-triglyceride-glucose-index-and-residual-syntax-score-in-stemi-patients-undergoing-ppci-100565444","NCT06642259","Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in STEMI Patients Undergoing PPCI","Correlation Between Triglyceride Glucose Index and Residual SYNTAX Score in ST-elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention","Inclusion Criteria:\n\n* All patient who are between 18 and 80 years old who present to our hospital (Assiut university heart hospital) with STEMI and eligible for primary PCI as treatment of choice according to guidelines, will be included in our study.\n\nExclusion Criteria:\n\n* Patient who refuse to undergo revasculariztion using primary PCI.\n* Patient who will die before withdraw of laboratory blood sample.\n* Patient with previous PCI and\u002For CABG.\n* Patient with underlying co-morbidity with life expectancy less than 1 year (end stage liver disease, end stage renal disease on regular dialysis, active malignancy).\n* Patient with failed canalization of infarct related artery.\n* Patient referred to CABG after angiography.\n* Patient who is unconscious after cardiac arrest .",{"count":420,"type":21},185,"The goal of this study To check correlation between triglyceride glucose (TyG) index and residual SYNTAX score (RSS) in STEMI patients undergoing PPCI.\n\n2\\. Impact of both TyG index and RSS in STEMI patients undergoing PPCI on LV EF recovery after 3 months using LV speckle tracking.\n\n3\\. Impact of RSS and TyG index in STEMI patients undergoing PPCI on short term MACE at 3 months duration.",[28],"2024-10-12",{"date":425,"type":42},"2024-10-15",{"date":427,"type":21},"2024-12-01",{"date":429,"type":21},"2028-12",{"name":431,"class":115},"Assiut University",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":61,"phases":442,"briefSummary":443,"conditions":444,"keywords":445,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":50},"100517090","phase-4-century-clot-guided-prophylactic-rivaroxaban-for-post-stemi-complicating-left-ventricular-thrombus-100517090","NCT06013020","Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus","Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy","Inclusion Criteria:\n\n* Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.\n* Patients provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Intracranial, gastrointestinal, or urogenital bleeding within 6 months\n* Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);\n* Bleeding diathesis, thrombocytopenia (platelet \\\u003C100,000\u002FmL) or hemoglobin \\\u003C10 g\u002FdL, and CRUSADE score-based high bleeding risk\n* Hepatic dysfunction (serum liver enzyme\\>3 times the normal limit)\n* Renal failure (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2 or requiring dialysis)\n* Severe chronic obstructive pulmonary disease\n* Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without pacemaker protection)\n* Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin\n* Life expectancy \\\u003C 1 year","75 Years",{"count":441,"type":21},374,[63],"To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation\u002Faggregation and thrombin generation, requires dual (platelet and coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge, since that increase in potential risk of bleeding.\n\nAlthough the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in modern reperfusion therapy, including primary percutaneous coronary intervention (PCI), remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited. How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and prevent LVT formation is challenging, since insufficient evidence is available from randomized trials.\n\nCentury Clot analyzer is point-of-care testing that could assess the coagulate state: normal, hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain.",[28],[446],"Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI","2024-03-16",{"date":449,"type":42},"2024-03-19",{"date":451,"type":21},"2024-04-01",{"date":453,"type":21},"2027-12-31",{"name":455,"class":115},"Zunyi Medical College",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":61,"phases":466,"briefSummary":467,"conditions":468,"keywords":477,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":153},"100396044","phase-4-what-is-the-optimal-antithrombotic-strategy-in-patients-with-atrial-fibrillation-undergoing-pci-100396044","NCT04436978","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?","What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?","WOEST-3","Inclusion Criteria:\n\n1. Patients ≥ 18 years\n2. Undergoing successful PCI (either ACS or elective PCI)\n3. History of or newly diagnosed (\\\u003C72 hours after PCI\u002FACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC\n\nExclusion Criteria:\n\n1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors\n2. Current indication for OAC besides atrial fibrillation\u002Fflutter (e.g. venous thromboembolism)\n3. \\\u003C12 months after any stroke\n4. CHADSVASc score ≥7\n5. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)\n6. Mechanical heart valve prosthesis\n7. Intracardiac thrombus or apical aneurysm requiring OAC\n8. Poor LV function (LVEF \\\u003C30%) with proven slow-flow\n9. History of intracranial haemorrhage\n10. Active bleeding on randomization\n11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved\n12. Recent (\\\u003C1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved.\n13. Known coagulopathy\n14. Severe anaemia requiring blood transfusion or thrombocytopenia \\\u003C50 × 109\u002FL\n15. BMI \\>40 or bariatric surgery\n16. Kidney failure (eGFR \\\u003C15)\n17. Active liver disease (ALT, ASP, AP \\>3x ULN or active hepatitis A, B or C)\n18. Active malignancy excluding non-melanoma skin cancer\n19. Life expectancy \\\u003C1 year\n20. Pregnancy or breast-feeding women",{"count":465,"type":21},2000,[63],"The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy.\n\nHowever, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest.\n\nThe WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.",[25,469,470,471,28,27,472,473,474,475,476],"Myocardial Infarction","Atrial Fibrillation","Atrial Flutter","Bleeding","Stroke","Stent Thrombosis","Embolism","Coronary Artery Disease",[25,469,470,471,28,27,478,479,480,481,482,483,484,472,485,473,474,486,487,488],"Oral Anticoagulant","NOAC - Novel Oral Anticoagulant","DOAC - Direct Oral Anticoagulant","DAPT - Dual Antiplatelet Therapy","Antithrombotic Therapy","Dual Therapy","Triple Therapy","Thrombosis","Systemic Embolism","Percutaneous coronary intervention","Coronary artery disease","2023-12-14",{"date":491,"type":42},"2023-12-15",{"date":493,"type":42},"2023-01-11",{"date":495,"type":21},"2027-12-01",{"name":497,"class":115},"St. Antonius Hospital",{"id":499,"slug":500,"hasResults":11,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":50},"100465977","predictors-of-failed-thrombolysis-in-acute-myocardial-infarction-100465977","NCT05347732","Predictors of Failed Thrombolysis in Acute Myocardial Infarction","Predictors of Failed Thrombolysis in Acute ST-segment Elevation Myocardial Infarction","TROFAMI","Inclusion Criteria:\n\nSTEMI patients \\> 18 years given prehospital thrombolysis.\n\nExclusion Criteria:\n\nNone.",{"count":398,"type":21},"The purpose of this observational study is to assess why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in patients with acute ST-segment elevation myocardial infarction (STEMI). The study will include 200 STEMI patients at the time of arrival at Oslo University Hospital Ullevål after receiving prehospital thrombolysis. A blood sample will be taken immediately for the study of factors related to coagulation, fibrinolysis and inflammation. Levels of the biomarkers will be compared between patients with successful and failed thrombolysis.",[28],"2023-03-22",{"date":511,"type":42},"2023-03-23",{"date":513,"type":42},"2022-04-25",{"date":515,"type":21},"2035-01-03",{"name":517,"class":115},"Oslo University Hospital"]