NCT05865600 Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome
| NCT ID | NCT05865600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gødstrup Hospital |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 570 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 570 participants in total. It began in 2023-05-23 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Morten Böttcher, Prof
PRINCIPAL INVESTIGATOR
University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital
Frequently Asked Questions
Who can join the NCT05865600 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05865600 currently recruiting?
Yes, NCT05865600 is actively recruiting participants. Contact the research team at jasoeb@rm.dk for enrollment information.
Where is the NCT05865600 trial being conducted?
This trial is being conducted at Herning, Denmark.
Who is sponsoring the NCT05865600 clinical trial?
NCT05865600 is sponsored by Gødstrup Hospital. The principal investigator is Morten Böttcher, Prof at University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital. The trial plans to enroll 570 participants.