Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome
NCT05865600 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570
Last updated 2025-12-10
Summary
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.
Conditions
- Chronic Coronary Syndrome
- Myocardial Ischemia
- Stable Angina
- Coronary Artery Disease
Interventions
- OTHER
-
Optimization of guideline-directed medical therapy
Consultation 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.
- DIAGNOSTIC_TEST
-
Immediate referral for invasive coronary angiography
Immediate referral for invasive coronary angiography
- DIAGNOSTIC_TEST
-
3-months delayed referral for invasive coronary angiography
3-months delayed referral for invasive coronary angiography
- OTHER
-
Standard of care
Standard of care
Sponsors & Collaborators
-
Gødstrup Hospital
lead OTHER
Principal Investigators
-
Morten Böttcher, Prof · University Clinic for Cardiovascular Research, Dept. of Cardiology, Gødstrup Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-23
- Primary Completion
- 2026-09-01
- Completion
- 2027-09-01
Countries
- Denmark
Study Locations
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