[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594546":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":36,"responsibleParty":51,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":68,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Beijing Chao Yang Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with at least one untreated CTOat basal angiography",null,"Total occlusion in any major coronary vessel or relevant side branches \\[reference vessel diameter \\>2.5 mm or as judged by two independent interventional cardiologists\\], with TIMI 0 in the distal segment and at least 3 months old",[13],"Diagnostic Test: FAPl lmaging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","FAPl lmaging","Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPl) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPl imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.",[9],[21],{"name":22,"affiliation":23,"role":24},"Lin Zhao, Dr","Beijing Chaoyang Hospital, Capital Medical University, Beijing, China","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Shengwen Yang, Dr","CONTACT","+8601085231480","+8617801014018","verayang1990@163.com",{"name":33,"role":28,"phone":29,"phoneExt":34,"email":35},"Bin Tu","+8618810682692","dr_bintu@163.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":10},"Beijing Chaoyang Hospital，Capital Medical University，Beijing，China","RECRUITING","Beijing","Beijing Municipality","100020","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Lin Zhao","Cheif of Cardiovascular department","100594546","fapi-imaging-predicts-adverse-cardiac-events-in-chronic-total-occlusion-100594546",false,"NCT07020858","FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion","The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)","FACT-2","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA).\n3. Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.\n4. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.\n2. Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.\n3. Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m².\n4. Life expectancy \\\u003C1 year due to non-cardiovascular comorbidities.\n5. Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).","ALL","18 Years",{"count":66,"type":67},470,"ESTIMATED","2 Years","OBSERVATIONAL","Prospective, observational, single-center cohort study\n\nHypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET\u002FCT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling.\n\nInclusion Criteria\n\n* Age ≥ 18 years\n* Presence of at least one untreated chronic total occlusion (CTO) lesion in a major coronary artery (diameter ≥ 2.5 mm, TIMI 0 flow for ≥ 3 months) confirmed by coronary angiography or CTCA\n* Patient eligible for PCI and undergoing FAPI PET\u002FCT imaging prior to intervention\n* Written informed consent provided\n\nExclusion Criteria\n\n* Allergy or contraindication to antiplatelet agents (aspirin, clopidogrel, or ticagrelor)\n* Severe liver dysfunction (liver enzymes \\>3× upper limit of normal)\n* Severe chronic kidney disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Estimated life expectancy \\\u003C 1 year\n* Pregnancy or potential for pregnancy\n\nPrimary Endpoint Incidence of 1-year MACE, defined as a composite of: Cardiac death, Myocardial infarction, Stroke, Urgent revascularization\n\nSecondary Endpoints\n\n* All-Cause Mortality\n* Death from any cause within 12 months\n* Quality of Life Change: Measured by Seattle Angina Questionnaire (SAQ): changes in angina frequency, physical limitation, and treatment satisfaction\n* Repeat PCI Events: Incidence of: In-stent restenosis (ISR): ≥50% luminal loss in previously stented segment; Target lesion revascularization (TLR): at original PCI lesion; Target vessel revascularization (TVR): other sites in same vessel; De novo lesions: new lesions not previously treated\n\nSample Size Estimated 470 patients\n\nFollow-Up Duration 12 months post-PCI, One follow-up visit including clinical exam, SAQ questionnaire, imaging (PET\u002FCT, echocardiography), and laboratory testing.",[72,73],"Chronic Total Occlusion (CTO)","Chronic Coronary Syndrome",[75,76,77,78,79,80],"Coronary Heart Disease","Major adverse cardiovascular events (MACE)","Plaque vulnerability","Optical coherence tomography (OCT)","Fibroblast activation protein inhibitor (FAPI)","Percutaneous coronary intervention (PCI)","2025-06-16",{"date":83,"type":84},"2025-06-19","ACTUAL",{"date":86,"type":84},"2025-04-15",{"date":88,"type":67},"2027-03-15",{"name":53,"class":6},1]