Clinical trial NCT05508893: Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
Official title: Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease (CAD)
Coronary Artery Calcification
Occupational Diseases
Aviator's; Disease
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Center for Man in Aviation, Royal Netherlands Air Force
First posted: 2022-08-19
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Every participant will perform an exercise test and receive a CTA afterwards
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
timeFrame: 8 Years
Secondary outcomes:
measure: Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA
timeFrame: 8 Years
measure: Compare the incidence of Major Adverse Cardiac Events (MACE) and all-cause mortality in populations screened between primary and secondary screening after 12 months
timeFrame: 8 Years
measure: 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
timeFrame: 8 Years
measure: Establish the additive value of coronary artery calcium score (CACS) in addition to clinical risk scores as a predictor of CAD on CCTA
timeFrame: 8 Years
Other outcomes:
Locations:
city: Soesterberg
country: Netherlands
facility: Center for Man in Aviation
state: Utrecht
city: Utrecht
country: Netherlands
facility: Utrecht University Medical Center
Study officials:
affiliation: UMC Utrecht
name: Hendrik Nathoe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Erik Frijters
role: PRINCIPAL_INVESTIGATOR
References: