Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome

Launched by GØDSTRUP HOSPITAL · May 9, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome" is studying the best way to help patients with chronic coronary syndrome, which includes issues like chest pain (angina) and heart blood flow problems. The trial will include 570 patients who have these symptoms and will use a special imaging test called 15O-water PET to look at how well blood is flowing in their hearts. Out of these patients, those who show abnormal blood flow will be randomly divided into two groups. One group will have an immediate heart procedure called invasive coronary angiography, while the other group will receive medical treatment first before considering the procedure later. The main goal is to see which approach provides better relief from chest pain after three months.

To be eligible for this trial, participants need to be over 18 years old, willing to sign a consent form, and have a history of heart problems, such as previous heart attacks or heart procedures. They must also have symptoms like chest pain or difficulty breathing and show specific abnormal results on the PET scan. Throughout the trial, participants will complete questionnaires to track their symptoms and will undergo follow-up imaging tests to monitor their heart health. It's important to note that certain conditions, like ongoing severe heart issues or specific allergies, may prevent someone from participating. This trial aims to find out how best to relieve symptoms for patients with chronic heart conditions, ultimately helping to improve their quality of life.

Gender

ALL

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