[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505762":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":53,"responsibleParty":72,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":30,"enrollmentInfo":84,"targetDuration":30,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":55,"whyStopped":30,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Gødstrup Hospital","OTHER",[8,13,20],{"label":9,"type":6,"description":10,"interventionNames":11},"Cohort study","All patients with symptomatic chronic coronary syndrome undergoing clinically referred \\[15O\\]H2O cardiac PET\u002FCT will be included in a prospective cohort with repeated symptom questionnaires and outcomes registered in national registries. A total of 570 patients are expected to be included in order to have 200 randomized patients reaching the 3-month assessment",[12],"Other: Standard of care",{"label":14,"type":15,"description":16,"interventionNames":17},"Immediate referral to invasive coronary angiography","EXPERIMENTAL","Patients with abnormal perfusion on \\[15O\\]H2O cardiac PET\u002FCT and clinical indication for invasive coronary angiography randomized to immediate referral for invasive coronary angiography with concomitant optimization of guideline-directed medical therapy. Enrollment will continue until a total of 200 randomized patients reach the 3-month assessment.",[18,19],"Other: Optimization of guideline-directed medical therapy","Diagnostic Test: Immediate referral for invasive coronary angiography",{"label":21,"type":15,"description":22,"interventionNames":23},"Delayed referral to invasive coronary angiography","Patients with abnormal perfusion on \\[15O\\]H2O cardiac PET\u002FCT and clinical indication for invasive coronary angiography randomized to 3-months delayed referral for invasive coronary angiography with concomitant optimization of guideline-directed medical therapy. Enrollment will continue until a total of 200 randomized patients reach the 3-month assessment.",[18,24],"Diagnostic Test: 3-months delayed referral for invasive coronary angiography",[26,31,35,38],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Optimization of guideline-directed medical therapy","Consultation every second week with optimization of guideline-directed medical therapy according to 2019 ESC guidelines on chronic coronary syndrome. Focus will be on risk-factor modification and anti-anginal medication with the treatment aim to achieve freedom from angina and dyspnea with a heart rate at rest ≤ 60 beats\u002Fmin and systolic blood pressure \\> 100 mmHg.",[21,14],null,{"type":32,"name":33,"description":33,"armGroupLabels":34,"otherNames":30},"DIAGNOSTIC_TEST","Immediate referral for invasive coronary angiography",[14],{"type":32,"name":36,"description":36,"armGroupLabels":37,"otherNames":30},"3-months delayed referral for invasive coronary angiography",[21],{"type":6,"name":39,"description":39,"armGroupLabels":40,"otherNames":30},"Standard of care",[9],[42],{"name":43,"affiliation":44,"role":45},"Morten Böttcher, Prof","University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Jacob H Søby, MD","CONTACT","61659131","0045","jasoeb@rm.dk",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Herning","Central Jutland","7400","Denmark","DK",{"type":62,"coordinates":63},"Point",[64,65],8.97662,56.13615,{"lat":65,"lon":64},[68,71],{"name":43,"role":49,"phone":69,"phoneExt":51,"email":70},"25775134","morboett@rm.dk",{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100505762","perfusion-estimation-for-optimal-treatment-strategy-in-chronic-coronary-syndrome-100505762",false,"NCT05865600","Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome","Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial","PERFORM-CCS","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Willing to participate and able to understand, read and sign the informed consent document before the planned procedure\n3. Known ischemic heart disease defined as one of the following\n\n   1. Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting\n   2. Previous coronary computed tomography angiography or invasive coronary angiography documenting atherosclerosis.\n4. Undergoing clinically indicated \\[15O\\]H2O cardiac PET\u002FCT due to chest discomfort or dyspnea as angina equivalent\n\n   Additional inclusion criteria for randomized trial:\n5. Initial \\[15O\\]H2O cardiac PET\u002FCT with abnormal perfusion defined as all of the following\n\n   1. Hyperemic myocardial blood flow (hMBF) ≤2.3 mL\u002Fmin\u002Fg in at least two adjacent myocardial segments\n   2. Relative hMBF ≤ 65% in at least two adjacent segments as compared with the mean hMBF of the two adjacent segments with the highest mean hMBF\n   3. Tissue perfusion defect extent ≥ 5% based on indices of relative hypoperfusion\n6. Clinical indication for invasive coronary angiography decided at a multidisciplinary conference between consultants in nuclear medicine and cardiology\n\nExclusion Criteria:\n\n1. Ongoing acute coronary syndrome or acute coronary syndrome within 30 days\n2. Contraindications for adenosine\n\n   1. Severe asthma\n   2. Advanced atrioventricular block without pacemaker\n   3. Severe aortic stenosis\n3. Patients not able to breath hold (severe COPD\u002Fasthma)\n4. Pregnant women, including women who are potentially pregnant or lactating\n5. Allergy to iomeron\n6. Life expectancy of less than 2 years\n7. Severe valvular disease\n8. Reduced kidney function with an estimated glomerular filtrations rate \\\u003C40 ml\u002Fmin\n9. Inability to consent\n\n   Additional exclusion criteria for randomized trial:\n10. Unprotected left main coronary artery stenosis on coronary CT angiography\n11. Very large perfusion defect on initial \\[15O\\]H2O cardiac PET\u002FCT indicating left main coronary artery stenosis or balanced ischemia defined as tissue perfusion defect extent based on indices of absolute hMBF ≥ 20% in two or more myocardial territories supplied by coronary arteries with an Agatston calcium score ≥ 300","ALL","18 Years",{"count":85,"type":86},570,"ESTIMATED","INTERVENTIONAL",[89],"NA","We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \\[15O\\]H2O cardiac PET\u002FCT in patients with symptomatic chronic coronary syndrome.",[92,93,94,95],"Chronic Coronary Syndrome","Myocardial Ischemia","Stable Angina","Coronary Artery Disease",[93,97,95,98,99,100],"Angina Pectoris","Coronary Angiography","Computed Tomography Angiography","Myocardial Perfusion Imaging","2025-12-03",{"date":103,"type":104},"2025-12-10","ACTUAL",{"date":106,"type":104},"2023-05-23",{"date":108,"type":86},"2027-09-01",{"name":5,"class":6},1]