Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome (PERFORM-CCS)
Chronic Coronary Syndrome, Myocardial Ischemia, Stable Angina
About this trial
This is an interventional treatment trial for Chronic Coronary Syndrome focused on measuring Myocardial Ischemia, Angina Pectoris, Coronary Artery Disease, Coronary Angiography, Computed Tomography Angiography, Myocardial Perfusion Imaging
Eligibility Criteria
Inclusion Criteria: Age > 18 years Willing to participate and able to understand, read and sign the informed consent document before the planned procedure Known ischemic heart disease defined as one of the following Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting Previous coronary computed tomography angiography or invasive coronary angiography documenting atherosclerosis. Undergoing clinically indicated [15O]H2O cardiac PET/CT due to chest discomfort or dyspnea as angina equivalent Additional inclusion criteria for randomized trial: Initial [15O]H2O cardiac PET/CT with abnormal perfusion defined as all of the following Hyperemic myocardial blood flow (hMBF) ≤2.3 mL/min/g in at least two adjacent myocardial segments 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 Tissue perfusion defect extent ≥ 5% based on indices of relative hypoperfusion Clinical indication for invasive coronary angiography decided at a multidisciplinary conference between consultants in nuclear medicine and cardiology Exclusion Criteria: Ongoing acute coronary syndrome or acute coronary syndrome within 30 days Contraindications for adenosine Severe asthma Advanced atrioventricular block without pacemaker Severe aortic stenosis Patients not able to breath hold (severe COPD/asthma) Pregnant women, including women who are potentially pregnant or lactating Allergy to iomeron Life expectancy of less than 2 years Severe valvular disease Reduced kidney function with an estimated glomerular filtrations rate <40 ml/min Inability to consent Additional exclusion criteria for randomized trial: Unprotected left main coronary artery stenosis on coronary CT angiography Very large perfusion defect on initial [15O]H2O cardiac PET/CT 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
Sites / Locations
- Gødstrup HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Experimental
Experimental
Cohort study
Immediate referral to invasive coronary angiography
Delayed referral to invasive coronary angiography
All patients with symptomatic chronic coronary syndrome undergoing clinically referred [15O]H2O cardiac PET/CT 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
Patients with abnormal perfusion on [15O]H2O cardiac PET/CT 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.
Patients with abnormal perfusion on [15O]H2O cardiac PET/CT 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.