Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)

Study Overview
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Brief Summary
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SUSPECT is a prospective, single-center, cohort study of 250 military aircrew at the Center for Man in Aviation, Royal Netherlands Air Force. All asymptomatic aircrew (≥40 years) are asked to undergo a coronary CT scan on a voluntary basis, following the exercise electrocardiograms performed at their routine aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.

Official Title
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Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)

Conditions
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Occupational Diseases, Coronary Artery Disease (CAD), Coronary Artery Calcification, Aviator's; Disease

Intervention / Treatment
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* Radiation: CT Angiography
* Diagnostic Test: Exercise stress test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Military aircrew of the Royal Netherlands Air Force ≥ 40 years old Required to undergo cardiac screening (per military aviation regulations) Exclusion Criteria: Typical angina Prior myocardial infarction Prior revascularization therapy (i.e. percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG)) Left ventricular ejection fraction <35% Does not comprehend study requirements, and/or is unwilling or unable to comply to study procedures CT-related contra-indications Allergic to iodine contrast. Renal insufficiency (GFR <60 ml/min/1.73m2, calculated with the Modification of Diet in Renal Disease (MDRD) calculator: http://nephron.org/mdrd_gfr_si. Severe claustrophobia. Uncontrolled irregular heart rhythm or tachycardia unresponsive to beta blockade Pregnancy

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Every participant will perform an exercise test and receive a CTA afterwards
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CT Angiography<br>Coronary CT Angiography will be performed on all individuals | Radiation: CT Angiography<br>* A CTA will be performed on asymptomatic individuals<br>|
| Other: Exercise stress test<br>An bicycle exercise stress test will be performed on all individuals | Diagnostic Test: Exercise stress test<br>* A routine exercise stress test will be performed on a bicycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool |  | 8 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA | Both modalities are used to track down clinically relevant CAD. Clinically relevant CAD is defined as a stenosis of >50%. | 8 Years | 
| Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months |  | 8 Years | 
| Compare the incidence of coronary angiograms and revascularization procedures in the population screened with CTA compared to a historical population using CTA as a secondary screening tool |  | 8 Years | 
| Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA |  | 8 Years |