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

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

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.

Study Overview

• Status: Terminated
• Conditions: Occupational Diseases; Coronary Artery Calcification; Coronary Artery Disease (CAD); Aviator's; Disease
• Intervention / Treatment: Radiation: CT Angiography; Diagnostic test: Exercise stress test

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Utrecht University Medical Center
  • Utrecht
    • Soesterberg, Utrecht, Netherlands, 3769 DE
      • Center for Man in Aviation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CT Angiography; Coronary CT Angiography will be performed on all individuals	Radiation: CT Angiography; A CTA will be performed on asymptomatic individuals
Other: Exercise stress test; An bicycle exercise stress test will be performed on all individuals	Diagnostic test: Exercise stress test; A routine exercise stress test will be performed on a bicycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Center for Man in Aviation, Royal Netherlands Air Force
• Investigators: Principal Investigator: Hendrik Nathoe, PhD, UMC Utrecht; Principal Investigator: Erik Frijters, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2014
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Occupational Diseases
• Other Study ID Numbers: 13-693/D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No