Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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Computed Tomography Versus Exercise Testing in Suspected Coronary Artery Disease

Conditions
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Angina Pectoris, Chest Pain

Intervention / Treatment
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* Other: Cardiac CT
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac CT<br>Cardiac CT (CT calcium and/or CT angiography), followed by stress testing, invasive angiography or neither depending on the CT scan result | Other: Cardiac CT<br>* Cardiac CT: calcium scan and CT coronary angiography<br>|
| Other: Standard care<br>Standard diagnostic management, including stress testing and/or invasive angiography | Other: Standard care<br>* Standard care according to international guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain | Reduction of chest pain symptoms by standardized questionnaire, at one year follow-up | 1 year | 
| Class IA Revascularizations | Number of revascularizations with an ESC class 1A indication | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall medical expenses | Overall medical expenses | 1 year | 
| Cost-effectiveness | Cost-effectiveness analysis based on the overall quality of life and medical expenses at one year. | 1 year | 
| Radiation dose | Cumulative radiation exposure at one year | 1 year | 
| Major adverse cardiovascular events | Composite endpoint of adverse cardiovascular events, including: All-cause mortality Non-fatal myocardial infarction Unstable angina requiring hospital admission Late revascularization procedures (>6 months after initial evaluation) | 1 year | 
| Quality of life | Change of quality of life at 1 year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, angina pectoris, Stable chest pain complaints