Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)

Study Overview
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Brief Summary
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Multi-center, randomized-controlled trial comparing a comprehensive cardiac CT protocol with standard stress testing in patients with stable chest pain complaints.

Detailed Description
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Rationale: CT calcium and coronary lumen imaging allow efficient exclusion of coronary artery disease (CAD), but cannot assess the hemodynamic significance of obstructive findings. Addition of stress myocardial perfusion imaging, which assesses the functional relevance of coronary narrowing, completes the non-invasive cardiac evaluation. Hypothesis: A comprehensive cardiac CT examination will allow fast, accurate and complete evaluation of suspected CAD. Objective: evaluate the effectiveness and efficiency of comprehensive cardiac CT workup of suspected CAD. Study design: Open-labelled, randomized-controlled, clinical efficiency trial, with an intention-to-diagnose approach, between CT-guided management and the current standard of care (based on functional testing of provocable myocardial ischemia) in patients with suspected CAD. Study population: 250 patients (>18 yrs) with stable chest complaints, a >10% pre-test probability of CAD, and referred for evaluation of possible CAD. Intervention: Instead of the usual diagnostic approach, patients in the intervention group will undergo in sequence the following CT examinations: coronary calcium scan, coronary CT angiography and CT myocardial perfusion imaging, with completion dependent on results. Findings on CT will direct further management. Main study parameters/endpoints: Primary: Rate of negative invasive angiograms (as percentage of total population) Secondary: Diagnostic yield, chest complaints, quality of life, diagnostic and therapeutic procedures, overall costs and adverse events at 6 months.

Official Title
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Comprehensive Cardiac CT Versus Exercise Testing in Suspected Coronary Artery Disease (2)

Conditions
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Stable Angina Pectoris, Coronary Artery Disease

Intervention / Treatment
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* Device: Cardiac CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged >18 years. Chest pain symptoms suspicious of coronary heart disease. Pre-test probability of coronary artery disease >10% Exclusion Criteria: History of CAD: prior myocardial infarction or revascularization procedure Contra-indication to radiation exposure (CT/SPECT): pregnancy Contra-indication to iodine contrast media: renal failure, iodine allergy Contra-indications to adenosine 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: Comprehensive cardiac CT<br>Tiered cardiac CT protocol: CT calcium scan CT angiography (if calcium scan positive or high pre-test probability) CT perfusion (if >50% stenosis on CTA, or cannot be ruled out) | Device: Cardiac CT scan<br>* CT-guided management<br>|
| No Intervention: Standard care<br>Standard diagnostic management of suspected CAD, using stress testing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of negative invasive angiograms (as percentage of total population) | Number of performed invasive angiograms with no CAD requiring intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain complaints | Proportion of patients experiencing symptoms of chest pain | 6 months | 
| Quality of life | Questionnaire based quality of life score | 6 months | 
| Major adverse event rate | Death, myocardial infarction, unstable angina, urgent revascularizations, CVA | 6 months | 
| Radiation exposure | Cumulative radiation dose from diagnostic and therapeutic interventions | 6 months | 
| Number of diagnostic and therapeutic procedures | Number of diagnostic and therapeutic procedures | 6 months | 
| Medical expenses | All medical expenses related to the diagnosis and treatment of suspected CAD | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed tomography, Coronary angiography, Coronary artery disease, Perfusion imaging, Comparative effectiveness, Randomized controlled trial, Cost-effectiveness