NCT05865600Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 2 May 2023
- Start date
- 23 May 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Gødstrup Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT05865600
What you commit to
- Study type: Interventional
- Planned participants: 570
- From 23 May 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing acute coronary syndrome or acute coronary syndrome within 30 days
- Allergy to iomeron
- Severe valvular disease
Lab values
- 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
Other
- 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
- Life expectancy of less than 2 years
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gødstrup Hospital Coordinator of this site? Confirm its status | Herning | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.