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New treatment option for Chronic Coronary Syndrome
Official title Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome
ClinicalTrials.gov ID: NCT05865600
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility criteria
- 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 for assigned by chance 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
- 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 Additional exclusion criteria for assigned by chance trial:
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Herning, Central Jutland, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herning, Central Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.