Assessing treatment strategies for chronic coronary syndrome
Perfusion Estimation for Optimal Revascularization and Medical Therapy in Chronic Coronary Syndrome - a Randomized Trial
This study is testing whether getting heart surgery sooner or sticking with medication helps people with chronic coronary syndrome feel better after three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 570 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gødstrup Hospital Academic / other |
| Locations | 1 site (Herning, Central Jutland) |
| Trial ID | NCT05865600 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a cohort of 570 patients with symptomatic chronic coronary syndrome who will undergo 15O-water PET imaging to evaluate their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomly assigned to either immediate or delayed referral for invasive coronary angiography, alongside optimization of guideline-directed medical therapy. The primary goal is to compare the effectiveness of early invasive coronary angiography versus medical therapy in relieving symptoms of angina after three months. The study will utilize advanced imaging techniques to guide treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with known ischemic heart disease and symptoms of chronic coronary syndrome.
Not a fit: Patients without ischemic heart disease or those who do not exhibit abnormal perfusion on initial imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved symptom relief and treatment strategies for patients with chronic coronary syndrome.
How similar studies have performed: Previous studies have shown promising results using similar imaging techniques for diagnosing and managing coronary artery disease, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Herning, Central Jutland
- Gødstrup Hospital — Herning, Central Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Morten Böttcher, Prof — University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital
- Study coordinator: Jacob H Søby, MD
- Email: jasoeb@rm.dk
- Phone: 61659131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.