Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Erasmus Medical Center
- Enrollment
- 350
- Locations
- 4
- Primary Endpoint
- Chest pain
Study Overview
Brief Summary
Direct non-invasive coronary imaging by computed tomography (CT) has the potential to improve the workup of patients with stable chest pain complaints. The objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a CT angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged >18 years.
- •Stable symptoms of chest pain or dyspnea potentially caused by obstructive CAD.
Exclusion Criteria
- •A history of surgical or percutaneous coronary revascularization
- •Non-revascularized angiographic obstructive coronary artery disease (>50% diameter reduction).
- •Normal invasive coronary angiography or stress imaging less than 1 years ago.
- •Inability or unwillingness to provide informed consent.
Arms & Interventions
Cardiac CT
Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result
Intervention: Cardiac CT (Other)
Standard care
Standard diagnostic management, including stress testing and/or invasive angiography
Intervention: Standard care (Other)
Outcomes
Primary Outcomes
Chest pain
Time Frame: 1 year
Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up
Class IA Revascularizations
Time Frame: 1 year
Number of revascularizations with an ESC class 1A indication
Secondary Outcomes
- Cost-effectiveness(1 year)
- Major adverse cardiovascular events(1 year)
- Overall medical expenses(1 year)
- Radiation dose(1 year)
- Quality of life(1 year)
Investigators
Koen Nieman
Dr K Nieman
Erasmus Medical Center