Coronary Artery Disease (CAD) Clinical Trial
— SUSPECTOfficial title:
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
Verified date | August 2022 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 250 |
Est. completion date | June 21, 2022 |
Est. primary completion date | June 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Center for Man in Aviation | Soesterberg | Utrecht |
Netherlands | Utrecht University Medical Center | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Center for Man in Aviation, Royal Netherlands Air Force |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool | 8 Years | ||
Secondary | 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 | |
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | 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 |
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