Assessing treatment strategies for chronic coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.