[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microvascular-obstruction-mvo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microvascular-obstruction-mvo":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100613307","for-patients-with-myocardial-infarction-and-multiple-vessel-testing-if-ultrasound-ufr-can-guide-all-needed-treatment-in-one-procedure-avoiding-a-return-hospital-visit-for-a-second-operation-100613307",false,"NCT07264881","For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.","A Prospective, Longitudinal, Multi-modal Study Evaluating the Utility of Acute Phase UFR (IVUS-FFR) to Predict Functional Significance in the Stable Phase for Patients With Acute Coronary Syndrome (ACS)","ACT-EVOLVE","Inclusion Criteria:\n\n* Age \\>18 years, any sex.\n* The participant is able to understand the study procedures and provides voluntary written informed consent.\n* Diagnosed with Acute Coronary Syndrome (ACS) and meets the criteria for one of the two pre-specified cohorts:\n* STEMI Cohort: Symptom onset \\\u003C 12 hours with ECG findings of ST-segment elevation myocardial infarction.\n* High-Risk NSTEMI Cohort: Meets at least one of the following: GRACE score \\> 140, dynamic ECG changes (ST-T), or significant Troponin elevation.\n* Has undergone successful emergency PCI of the Culprit Vessel (CV), with post-PCI TIMI flow Grade 3.\n* Coronary angiography confirms Multi-vessel Disease (MVD), defined as: at least one Non-Culprit Vessel (NCV) with a moderate stenosis (visual diameter stenosis 50-90%).\n* The target NCV (50-90% stenosis) is deemed by the investigator to be anatomically suitable for IVUS and pressure-wire assessment.\n* The participant agrees and is confirmed to be willing and able to strictly adhere to the protocol and complete all required invasive procedures, CMR scans, and follow-ups at the four timepoints (T0, T-CMR, T1, T2).\n\nExclusion Criteria:\n\n* Presence of cardiogenic shock on presentation, or persistent hemodynamic instability despite successful PCI of the culprit vessel.\n* Known severe allergy to iodinated contrast media or gadolinium-based contrast agents (used for CMR).\n* Female participants who are pregnant, breastfeeding, or planning pregnancy within the 1-year study period.Unprotected left main coronary artery disease (stenosis \\\u003C50%) requiring intervention.\n* Prior history of Coronary Artery Bypass Grafting (CABG) surgery.The target NCV has received prior PCI (e.g., existing stent) or surgical revascularization.\n* The target NCV is a Chronic Total Occlusion (CTO).\n* Severe renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m²) or currently undergoing chronic dialysis.\n* Standard contraindications to CMR examination (e.g., claustrophobia, non-MRI-compatible metallic implants\u002Fpacemakers).\n* Known presence of a severe non-cardiac comorbidity with an expected lifespan of \\\u003C 12 months (e.g., advanced malignancy).\n* Known severe hematological disease (e.g., severe anemia, active bleeding, thrombocytopenia \\\u003C 70 x 10⁹\u002FL) rendering the participant unsuitable for multiple invasive procedures.\n* Inability to provide informed consent or comply with the complex longitudinal follow-up protocol due to psychiatric, cognitive, or other reasons.\n* Currently participating in another interventional (drug or device) clinical study.\n* Any other condition which, in the investigator's opinion, makes the participant unsuitable for enrollment (e.g., severe valvular heart disease, cardiomyopathy).","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Brief Summary The Purpose of the Study : The purpose of this study is to find a safe and reliable \"one-stop\" solution for treating heart attack patients who have multiple blocked arteries. Currently, doctors face a dilemma: Testing these other blockages during the heart attack procedure is often unreliable.\n\nThe most accurate method requires asking the patient to return 30 days later for a second invasive procedure, which is a significant burden.\n\nThe Study's Hypothesis : We are testing a new tool called UFR, which uses ultrasound images to measure blockages. Our hypothesis (or \"educated guess\") is that this new UFR tool is not affected by the body's stress during a heart attack and can provide a true, reliable measurement right away.\n\nThe Question the Study is Trying to Answer ： The main question this study is trying to answer is: Can the new \"one-stop\" UFR tool, used during the initial heart attack procedure, accurately predict which blockages are truly serious... thereby eliminating the need for patients to return for a second procedure 30 days later? Researchers will also follow 200 patients for one year, using advanced scans (like UFR, standard tests, and MRI), to better understand how the heart and arteries heal and change over time.",[25,26,27,28],"Microvascular Obstruction (MVO)","Multivessel Coronary Artery Disease","ACS (Acute Coronary Syndrome)","ST Elevation Myocardial Infarction (STEMI)",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Acute Coronary Syndrome","Fractional Flow Reserve,","Intravascular Ultrasound","Virtual Fractional Flow Reserve","Functional Drift","Coronary Microvascular Dysfunction","Index of Microcirculatory Resistance","Non-Culprit Vessel","ST Elevation Myocardial Infarction","Non-ST Elevation Myocardial Infarction","Cardiac Magnetic Resonance","Microvascular Obstruction","Staged Revascularization","Computational Fluid Dynamics","NOT_YET_RECRUITING","2025-11-24",{"date":47,"type":48},"2025-12-04","ACTUAL",{"date":50,"type":21},"2025-12-02",{"date":52,"type":21},"2028-06-22",{"name":54,"class":55},"Beijing Anzhen Hospital","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"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":20,"type":21},"INTERVENTIONAL",[67],"NA","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.",[25,70],"STEMI - ST Elevation Myocardial Infarction","2025-07-07",{"date":73,"type":48},"2025-07-10",{"date":75,"type":21},"2025-09-01",{"date":77,"type":21},"2026-12-01",{"name":79,"class":80},"CorFlow Therapeutics AG","INDUSTRY"]