Coronary Artery Disease Clinical Trial
— PERFORM-CCSOfficial title:
Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial
Verified date | May 2023 |
Source | Gødstrup Hospital |
Contact | Jacob H Søby, MD |
Phone | 61659131 |
jasoeb[@]rm.dk | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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/CT in patients with symptomatic chronic coronary syndrome.
Status | Recruiting |
Enrollment | 570 |
Est. completion date | September 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age > 18 years 2. Willing to participate and able to understand, read and sign the informed consent document before the planned procedure 3. Known ischemic heart disease defined as one of the following 1. Previous myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting 2. Previous coronary computed tomography angiography or invasive coronary angiography documenting atherosclerosis. 4. Undergoing clinically indicated [15O]H2O cardiac PET/CT due to chest discomfort or dyspnea as angina equivalent Additional inclusion criteria for randomized trial: 5. Initial [15O]H2O cardiac PET/CT with abnormal perfusion defined as all of the following 1. Hyperemic myocardial blood flow (hMBF) =2.3 mL/min/g in at least two adjacent myocardial segments 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 3. Tissue perfusion defect extent = 5% based on indices of relative hypoperfusion 6. Clinical indication for invasive coronary angiography decided at a multidisciplinary conference between consultants in nuclear medicine and cardiology Exclusion Criteria: 1. Ongoing acute coronary syndrome or acute coronary syndrome within 30 days 2. Contraindications for adenosine 1. Severe asthma 2. Advanced atrioventricular block without pacemaker 3. Severe aortic stenosis 3. Patients not able to breath hold (severe COPD/asthma) 4. Pregnant women, including women who are potentially pregnant or lactating 5. Allergy to iomeron 6. Life expectancy of less than 2 years 7. Severe valvular disease 8. Reduced kidney function with an estimated glomerular filtrations rate <40 ml/min 9. Inability to consent Additional exclusion criteria for randomized trial: 10. Unprotected left main coronary artery stenosis on coronary CT angiography 11. 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Gødstrup Hospital | Herning | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
Gødstrup Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptomatic relief | Seattle Angina Questionnaire-7 angina frequency score = 100 (0-100 with higher scores indicating less frequent angina) | After 3 months following a positive [15O]H2O cardiac PET/CT | |
Secondary | Walking capacity | Meters walked in six-minute walking test | 3 and 6 months after randomization | |
Secondary | Angina frequency | Seattle Angina Questionnaire-7 angina frequency score (0-100 with higher scores indicating less frequent angina) | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Physical limitation | Seattle Angina Questionnaire-7 physical limitation score (0-100 with higher scores indicating less physical limitation) | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Quality of life-score | Seattle Angina Questionnaire-7 quality of life score (0-100 with higher scores indicating better quality of life) | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Health status | Seattle Angina Questionnaire-7 summary score (0-100 where 0 denotes the lowest reportable health status and 100 the highest) | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Dyspnea | Rose Dyspnea Scale. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Work Ischemic Symptom score | Work Ischemic Symptom score summary score. The scoring system is currently under development. | 3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Hyperemic myocardial blood flow | Global and territorial hyperemic myocardial blood flow (ml/g/min) of perfusable myocardium on [15O]H2O cardiac PET/CT. | 3 and 6 months after randomization | |
Secondary | Myocardial flow reserve | Global and territorial myocardial flow reserve (unitless measure) on [15O]H2O cardiac PET/CT. | 3 and 6 months after randomization | |
Secondary | Coronary flow capacity | Coronary flow capacity incorporates hyperemic myocardial blood flow and myocardial flow reserve into a 5-point ordinal scale ranging from myocardial steal indicating very poor coronary flow capacity to normal coronary flow capacity. All data is derived from [15O]H2O cardiac PET/CT. | 3 and 6 months after randomization | |
Secondary | Coronary revascularization | Percutaneous coronary intervention and/or coronary artery bypass grafting | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Coronary revascularization | Percutaneous coronary intervention and/or coronary artery bypass grafting | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Myocardial infarction | All myocardial infarctions | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Myocardial infarction | All myocardial infarctions | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | All-cause mortality | All deaths | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | All-cause mortality | All deaths | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Cardiovascular mortality | All cardiovascular deaths | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Cardiovascular mortality | All cardiovascular deaths | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Unstable angina | Unstable angina | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Unstable angina | Unstable angina | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Unplanned hospitalization | Any hospitalization requiring overnight stay not electively planned | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Unplanned hospitalization | Any hospitalization requiring overnight stay not electively planned | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | De novo heart failure | New diagnosis of heart failure | 3 and 6 months after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | De novo heart failure | New diagnosis of heart failure | 10 years after randomization or index [15O]H2O cardiac PET/CT | |
Secondary | Use of CCTA, MPI, and ICA | Use of coronary CT angiography, myocardial perfusion imaging and invasive coronary angiography | 10 years after randomization or index [15O]H2O cardiac PET/CT |
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