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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Optimization of guideline-directed medical therapy
Other interventionConsultation 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
Diagnostic testImmediate referral for invasive coronary angiography
3-months delayed referral for invasive coronary angiography
Diagnostic test3-months delayed referral for invasive coronary angiography
Standard of care
Other interventionStandard of care
Treatment groups
570 Participants
are divided into 3 treatment groupsGroup A: Cohort studyOther 1 intervention
Group B: Immediate referral to invasive coronary angiographyExperimental treatment 2 interventions
Group C: Delayed referral to invasive coronary angiographyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Symptomatic relief
Seattle Angina Questionnaire-7 angina frequency score = 100 (0-100 with higher scores indicating less frequent angina)
Time frame
After 3 months following a positive [15O]H2O cardiac PET/CTSecondary outcomes
1
Walking capacity
Meters walked in six-minute walking test
Time frame
3 and 6 months after randomization2
Angina frequency
Seattle Angina Questionnaire-7 angina frequency score (0-100 with higher scores indicating less frequent angina)
Time frame
3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT3
Physical limitation
Seattle Angina Questionnaire-7 physical limitation score (0-100 with higher scores indicating less physical limitation)
Time frame
3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CT4
Quality of life-score
Seattle Angina Questionnaire-7 quality of life score (0-100 with higher scores indicating better quality of life)
Time frame
3, 6, 12, 60, and 120 months after randomization or index [15O]H2O cardiac PET/CTSponsors and contacts
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Source ClinicalTrials.gov