Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGødstrup Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Ongoing acute coronary syndrome or acute coronary syndrome within 30 days
Contraindications for adenosine
Severe asthma
Advanced atrioventricular block without pacemaker
Trial design
Treatments tested in this trial
- Optimization of guideline-directed medical therapy
- Immediate referral for invasive coronary angiography
- 3-months delayed referral for invasive coronary angiography
- Standard of care
Treatment groups
570 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov