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
Gødstrup Hospital
570 participants
May 23, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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
- 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 Criteria14
- 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
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Consultation every second week with optimization of guideline-directed medical therapy according to 2019 ESC guidelines on chronic coronary syndrome. Focus will be on risk-factor modification and anti-anginal medication with the treatment aim to achieve freedom from angina and dyspnea with a heart rate at rest ≤ 60 beats/min and systolic blood pressure \> 100 mmHg.
Immediate referral for invasive coronary angiography
3-months delayed referral for invasive coronary angiography
Standard of care
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05865600