[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stemi-st-elevation-mi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stemi-st-elevation-mi":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,82,110,145,173],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100620809","phase-2-prevention-of-reperfusion-injury-outcomes-through-effective-cardioprotection-targeting-myocardial-infarction-100620809",false,"NCT07362446","Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction","A Randomised, Double-Blind, Placebo-Controlled, Study of Xolatryp in Patients Presenting With STEMI Undergoing Primary PCI","PROTECT-MI","Inclusion Criteria:\n\n* Have provided informed consent.\n* Male patients aged 40 to 75 years of age.- Female patients aged 55 to 75 years of age, or women aged 40 to 55 years that have no possibility of being pregnant.\n* Patient presents with first-time STEMI, scheduled to undergo primary PCI within 6 h of symptom onset and anticipated door to balloon time \\\u003C 2 h.\n* In combination with symptoms consistent with acute MI, patient must demonstrate ST-elevation at the J-point in two contiguous leads.\n* Hemodynamically stable including: systolic BP ≥ 90 mmHg, HR 50-120 bpm.\n* Killip Class I or II.\n* Oxygen saturation ≥ 92% on room air or low-flow oxygen.\n* No ongoing VT\u002FVF at enrolment.\n* Male participants with female partners of child-bearing potential must be ready and able to use highly effective methods of birth control for at least 7 days following IP administration.\n\nExclusion Criteria:\n\n* History or ECG evidence of myocardial infarction or cardiomyopathy.\n* Prior major cardiac surgery, including but not limited to coronary artery bypass graft surgery (CABG).\n* Known contraindication to CMR (e.g. pacemakers, cochlear implants, aneurism clips, claustrophobia, allergy to contrast medium).\n* History of clinically significant renal impairment requiring dialysis or an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin.\n* Estimated or known body weight \\\u003C 50 kg, \\> 120 kg at screening.\n* Concurrent enrolment in another investigational device or drug trial, or less than 30 days or 5 half-lives of investigational device or drug (whichever is longer), since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients who are participating in non-interventional, purely observational trials can be included.\n* Life expectancy of less than 1 year due to non-cardiac pathology in the opinion of the Investigator.\n* Any condition or significant clinical abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study.\n* Known history of hypersensitivity to the investigational drug, or excipients, or do not want to be exposed to soy or egg (including products and derivatives).","ALL","40 Years","75 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study.\n\nParticipants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days.\n\nPlacebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30.\n\nHeart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.",[28,29,30,31],"Myocardial Infarction","Reperfusion Injury","AMI","STEMI (ST Elevation MI)",[33,34],"STEMI","PCI","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2026-04-22",{"date":43,"type":22},"2027-09-30",{"name":45,"class":46},"Nyrada Pty Ltd","INDUSTRY",7,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"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.","18 Years","80 Years",{"count":58,"type":22},70,[25],"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.",[31,62,33,63,64],"STEMI - ST Elevation Myocardial Infarction","CMD","Coronary Microvascular Dysfunction (CMD)",[66,67,68,69,70],"TCM","traditional chinese medicine","guanxinning tablet","CMR","intramyocardial hemorrhage","NOT_YET_RECRUITING","2026-05-27",{"date":74,"type":39},"2026-06-02",{"date":76,"type":22},"2026-06-01",{"date":78,"type":22},"2027-02-01",{"name":80,"class":81},"Beijing Anzhen Hospital","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100622230","phase-2-inhibition-of-late-sodium-current-ina-to-prevent-coronary-microvascular-dysfunction-in-patients-presenting-with-st-elevation-myocardial-infarction-and-multivessel-disease-inamicron-study-100622230","NCT07380919","Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study","Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: A Multicenter, Randomized, Controlled and Open Label Study (INaMICRON Study)","INaMICRON","Inclusion Criteria\n\n1. Age ≥ 18 years and \\\u003C 80 years on day of signing informed consent\n2. Ability to provide written informed consent in a time window 0 to 1 day after successful pPCI\n3. ST-Elevation Myocardial Infarction at the time of the index hospitalization.\n4. Successful pPCI (Thrombolysis In Myocardial Infarction \\[TIMI\\] flow 3 and residual coronary stenosis \\\u003C30%)\n5. Presence of at least one remaining angiographically significant (% diameter stenosis \\> 50%) non-culprit stenosis treatable with PCI\n6. Evidence of post-menopausal status or negative urinary or serum pregnancy test for child-bearing potential patients (definitions reported in section 10.9)\n7. Agreement for child-bearing potential patients who are sexually active to use contraception (definitions reported in section 10.10)\n\nExclusion Criteria:\n\n1. Hemodynamically unstable patients\n2. Previous myocardial infarction\n3. Previous coronary artery by-pass graft (CABG)\n4. Female patients with a positive pregnancy test at enrollment or prior to administration of study medication.\n5. Female patients who are pregnant or breastfeeding or reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of Ranolazine\n6. Known hypersensitivity to the active principle (Ranolazine) or any of the excipients\n7. Chronic Kidney Disease Stage 4 or 5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m 2)\n8. Moderate to severe liver failure (Child Pugh B - C)\n9. Simultaneous intake of the following classes of drugs: strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole); HIV protease inhibitors (i.e. saquinavir, indinavir, ritonavir); class Ia antiarrhythmic drugs (i.e. ajmaline, disopyramide, procainamide, quinidine ) and class III antiarrhythmic drugs except amiodarone (i.e. dofetilide, sotalol)\n10. Previous participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.",{"count":91,"type":22},100,[25,93],"PHASE3","This is a Phase IIb, multicentric, prospective, randomized (1:1 ratio), open label, and no profit study, with the aim of evaluating the efficacy of late INa current inhibition to improve coronary microcirculation in patients presenting with acute myocardial infarction and multivessel disease.\n\nAll consecutive patients presenting with acute MI undergoing primary PCI (pPCI) on a major coronary artery, and with at least one remaining angiographically significant (% diameter stenosis \\> 50%) non-culprit stenosis will be enrolled.\n\nThe primary objective of the study is to evaluate the potential effect of Ranolazine in preserving coronary microcirculation subtended to the culprit vessel as compared with control group. Coronary microcirculation will be assessed both at the time of the culprit lesion revascularization and within 6+\u002F-2 weeks by measuring the Index of Microcirculatory Resistance (IMR) either invasively or derived by the angiography (angioIMR).\n\nIn addition, the following secondary endpoints will be assessed: 1. The prevalence of residual CMD downstream to the culprit vessel in all patients (CMDculprit). CMDculprit will be defined as the finding of an IMR\u002FangioIMR value \\> 25, assessed after successful pPCI.\n\n2\\. The prevalence of CMD downstream to the non-culprit vessel in the two group of patients (CMDnon-culprit). CMDnon-culprit will be defined as the finding of an IMRnon-culprit or an angioIMRnon-culprit value \\> 25. IMRnon-culprit or angioIMRnon-culprit will be assessed at the time of staged PCI of the non-culprit stenosis.\n\n3\\. The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMR values assessed before and after elective PCI of the non-culprit vessel (CMDprocedural).\n\n4\\. The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure.\n\n5\\. The effects of INa current inhibition on endothelial function assessed at follow up as compared with control group.\n\n6\\. The extent of the Infarct Size, as assessed by the CMR, as compared with control group.\n\n7\\. The incidence of MACE, defined as composite of death, myocardial infarction, periprocedural MI, or any unplanned percutaneous coronary revascularization at short (42+\u002F-7 days) term follow-up.\n\n8\\. Angina symptoms and quality of life",[31],[33,97,98,99],"Coronary Microvascular Dysfunction","Ranolazine","Multivessel Coronary Artery Disease","2026-03-09",{"date":102,"type":39},"2026-03-11",{"date":104,"type":22},"2026-02",{"date":106,"type":22},"2026-06",{"name":108,"class":81},"Federico II University",3,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100612716","phase-3-aspirin-free-strategy-with-ticagrelor-in-patients-with-a-myocardial-infarction-treated-medically-alone-100612716","NCT07257198","Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone","Evaluation of an asPirin-free Strategy With ticAgrelor in patieNTs witH a Myocardial Infarction treatEd Medically alONe (PANTHEON)","PANTHEON","Inclusion criteria:\n\n* Age ≥18 years;\n* Hospitalized for type 1 MI, according to the 4th Universal Definition of MI;\n* Coronary angiogram performed;\n* Planned for medical management alone, without revascularization;\n* Willingness to participate and to attend study visits;\n* Expected life expectancy ≥12 months.\n\nExclusion criteria:\n\n* Patients hospitalized for type 2-5 MI, or unstable angina, according to the 4th Universal Definition of MI;\n* Patients hospitalized for a STEMI with an acute thrombotic lesion of a major epicardial vessel;\n* Elevations in cardiac biomarkers (troponins or CK-MB) that is believed by the investigator not to be of ischemic origin (e.g. myocardial injury, myocarditis, Takotsubo syndrome, etc.);\n* Confirmed or suspected spontaneous coronary artery dissection;\n* Concomitant indication for chronic oral anticoagulant;\n* Concomitant non-coronary indication for dual antiplatelet therapy;\n* Use of any non-trial antiplatelet drug that needs to be continued based on the judgement of the treating physician;\n* Previous hospitalization for MI, PCI, or CABG within 12 months;\n* Known hypersensitivity, intolerance, or contra-indication to ASA or ticagrelor;\n* Unsuitability for either randomization treatment, based on the judgement of the treating physician",{"count":119,"type":22},2570,[93],"In patients with a myocardial infarction (MI) treated medically alone, the objective of the PANTHEON trial is to evaluate if ticagrelor monotherapy reduces bleeding events, without an increase in patient-oriented ischemic events, compared with standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for 12 months.",[123,31,28],"NSTEMI - Non-ST Segment Elevation MI",[125,126,127,33,128,129,130,131,132,133,134],"Dual antiplatelet therapy","NSTEMI","medical treatment","aspirin","ticagrelor","bleeding","ischemic events","randomized trial","pragmatic trial","randomized controlled trial","2026-03-08",{"date":137,"type":39},"2026-03-10",{"date":139,"type":39},"2026-03-03",{"date":141,"type":22},"2031-01-01",{"name":143,"class":81},"Montreal Heart Institute",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":144},"100610566","phase-3-dcb-vs-des-in-young-stemi-patients-the-dcb-stemi-trial-100610566","NCT07229248","DCB vs. DES in Young STEMI Patients: The DCB-STEMI Trial","Drug Coated Balloon vs. Drug Eluting Stent in Young Patients With STEMI: The DCB-STEMI Randomized Trial","DCB-STEMI","Inclusion Criteria:\n\n* Either gender\n* Patient of age between 18 to 50 years\n* Patients with STEMI ( as first presentation of CAD) undergoing Primary PCI\n* Total ischemic Time less than 8 hrs.\n* Low syntax score\n* Stable (Killip I-II)\n\nExclusion Criteria:\n\n* Patients with ESRD\n* Severe 3 VD; Intermediate of High syntax score\n* Lesion type\\>B","49 Years",{"count":155,"type":22},496,[93],"Background: ST Elevation Myocardial Infarction (STEMI) in young adults (\\\u003C50 yrs) carries high Percutaneous coronary intervention (PCI) risks. While drug-eluting stents (DES) reduce restenosis versus angioplasty, they increase risks of in-stent restenosis, thrombosis, prolonged dual antiplatelet therapy (DAPT), and endothelial dysfunction. Drug-coated balloons (DCB) provide a \"leave nothing behind\" strategy, potentially mitigating these issues. Evidence, including a JACC CVI report, suggests DCB outcomes comparable to DES in STEMI. South Asia faces a heavy burden. The national Institute of Cardiovascular diseases (NICVD), Karachi performed 17,761 primary PCIs in 2022, with 45% in patients \\\u003C50 yrs.\n\nStudy Design: This single-center Randomized Controlled Trial (RCT) compares paclitaxel-coated DCB (3.0 µg\u002Fmm², 30s inflation) vs. Drug eluting stents (DES) in young STEMI patients (\\\u003C50 yrs) undergoing primary PCI. The primary endpoint is 1-year vessel oriented cardiac events (VOCE)= Cardiovascular \u002Fall-cause death, target vessel MI, or Target lesion revascularization (TLR). Secondary endpoints include vessel-oriented CV events, bleeding, TIMI III flow, residual stenosis, abrupt closure, and bailout stenting. An intravascular ultrasound (IVUS) substudy (100 DCB pts) will evaluate remodeling and late lumen loss (LLL) at 6 months.\n\nMethods: 496 patients (248\u002Farm) will be randomized 1:1, powered for non-inferiority (margin 4.5%) assuming VOCE 8.5% (DES) vs. 6.25% (DCB), 80% power, and 5% dropout. Inclusion: age 18-50, STEMI. Exclusion: End stage renal disease (ESRD), severe multivessel disease, complex lesions, or high thrombus burden. All will receive ticagrelor 90 mg BID for 1 month. A pilot of 50 pts will first assess safety (abrupt closure, lesion prep).\n\nAnalysis: Intention-to-treat (ITT) will be primary; modified ITT for secondary endpoints. Statistics include chi-square\u002FFisher for categorical, t-test\u002FWilcoxon for continuous, and Kaplan-Meier\u002FCox for survival. Oversight by data safety monitoring board (DSMB) and Events adjudication Committee (EAC).\n\nSignificance: This trial leverages NICVD's high PCI volume to test DCB as an alternative to DES in young STEMI patients. By avoiding permanent implants, DCB may reduce long-term complications and DAPT needs. The IVUS substudy and pilot phase strengthen rigor. If non-inferiority is proven, DCB could reshape STEMI management in South Asia and similar high-burden regions.",[31],[160,33,161,162,163],"Drug coated balloon","RCT","DES","MACE","2025-11-13",{"date":166,"type":39},"2025-11-14",{"date":168,"type":22},"2025-11-05",{"date":170,"type":22},"2027-12-26",{"name":172,"class":81},"National Institute of Cardiovascular Diseases, Pakistan",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100587976","phase-2-randomised-evaluation-of-therapies-for-microvascular-injury-in-steacs-100587976","NCT06935383","Randomised EValuation of Therapies for microvAscuLar Injury in STEACS","REVITALISE","Inclusion Criteria:\n\nCLINICAL criteria\n\n1. Subjects age ≥18 years old\n2. Ability to provide informed assent\u002Fconsent to the study according to GCP, governing regulations and approved process\n3. Infarct-related lesion in proximal or mid left anterior descending coronary artery\n4. ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women\n5. Symptoms onset to balloon time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea\u002Fvomiting, fatigue, palpitations or syncope) ≤ 6 h\n6. Suitability for Primary PCI\n\n   PPCI and Angiographic\n7. Culprit lesion in the LAD that is suitable for stenting\n8. COFI ballon can be placed according to IFU\n9. Required stent diameter ≥ 2.75 mm and ≤ 5mm and stent length ≥ 15 mm\n\nExclusion Criteria:\n\nCLINICAL criteria\n\n1. Unconscious on presentation\n2. Patients under judicial protection, legal guardianship or curatorship\n3. Mental disorder or language barrier that precludes informed assent\u002Fconsent GCP, governing regulations and approved process\n4. Known severe kidney disease (estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin) or on haemodialysis\n5. Pericardial effusion (cardiac tamponade)\n6. Cardiogenic shock and\u002For persistence of cardiogenic shock at completion of primary PCI. Cardiogenic shock defined as a. hypotension (systolic blood pressure below 100 mm Hg or an ongoing need for vasopressor support), and b. end-organ hypoperfusion with an arterial lactate level of 2.5 mmol\u002FL or greater\n7. Subject with previous MI and\u002For known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, ventricular Septal defect, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or regurgitation, pericardial disease\n8. Major bleeding ≤ 30d prior to intervention defined according to BARC 3-5\n9. Major surgery ≤ 30d prior to intervention\n10. History of stroke, TIA or reversible ischemic neurological deficit within last 6 months\n11. Known coagulopathy\n12. Treatment with oral anticoagulation therapy\n13. Need for circulatory support or pre\u002Fintra-procedural ventilation\n14. Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 min\n15. Heart failure with inotrope support and\u002For consideration for LVAD or heart transplant\n16. 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\n17. Current participation in another clinical study\n18. Known Pregnancy or breast feeding\n\n    If CMRI substudy to be confirmed at the time of consent to the substudy:\n19. 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\nPPCI and Angiographic criteria 19. Functional coronary collateral supply (Rentrop grade 2\u002F3) to the infarct-related artery 20. Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate\u002Fheavy calcification) preventing successful wiring with pressure wire 21. Cardiac condition preventing the use of the CoFI System 22. Any pre or post stenting condition that the physician believes requires a pharmacological iv or ic drug administration for a cardiac related condition to be administered before or during stenting, apart from standard of care administration of anaesthetics, heparin, nitrates or verapamil",{"count":181,"type":22},250,[25],"The goal of this interventional study is to evaluate if the CoFI system can act as a platform for intracoronary infusion of therapeutic agents to treat and relieve microvascular injury in ST Elevation Acute Coronary Syndrome (ACS) subjects diagnosed with MicroVascular Obstruction (MVO) after Primary Percutaneous Intervention (PPCI) and to quantify (identify) markers of treatment efficacy for CoFI mediated therapeutic agents infusion versus control.\n\nThe targeted population is subjects presenting with an ST elevation myocardial infarction and undergoing PPCI as per standard of care.\n\nEnrolled STEMI subjects will be examined for MVO with the CoFI system. Primary endpoint of the study is EF by TTE at 6 months.\n\nIf detected with MVO with the CoFI system, the subjects will be randomized and will receive treatment with medicinal product(s).",[31],"2025-04-17",{"date":187,"type":39},"2025-04-20",{"date":189,"type":22},"2025-09",{"date":191,"type":22},"2027-09",{"name":193,"class":46},"CorFlow Therapeutics AG"]