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

Sponsor
UMC Utrecht (Other)
Overall Status
Terminated
CT.gov ID
NCT05508893
Collaborator
Royal Netherlands Air Force (Other)
250
Enrollment
2
Locations
2
Arms
91.1
Actual Duration (Months)
125
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: CT Angiography
  • Diagnostic Test: Exercise stress test
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Every participant will perform an exercise test and receive a CTA afterwardsEvery participant will perform an exercise test and receive a CTA afterwards
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
Actual Study Start Date :
Nov 17, 2014
Actual Primary Completion Date :
Jun 21, 2022
Actual Study Completion Date :
Jun 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: CT Angiography

Radiation: CT Angiography
A CTA will be performed on asymptomatic individuals
Other: Exercise stress test

Diagnostic Test: Exercise stress test
A routine exercise stress test will be performed on a bicycle

Outcome Measures

Primary Outcome Measures

  1. Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool [8 Years]

Secondary Outcome Measures

  1. Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA [8 Years]

    Both modalities are used to track down clinically relevant CAD. Clinically relevant CAD is defined as a stenosis of >50%.

  2. 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]

  3. 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]

  4. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Man in Aviation Soesterberg Utrecht Netherlands 3769 DE
2 Utrecht University Medical Center Utrecht Netherlands 3584 CX

Sponsors and Collaborators

  • UMC Utrecht
  • Royal Netherlands Air Force

Investigators

  • Principal Investigator: Hendrik Nathoe, PhD, UMC Utrecht
  • Principal Investigator: Erik Frijters, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erik Frijters, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT05508893
Other Study ID Numbers:
  • 13-693/D
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Occupational Diseases

Study Results

No Results Posted as of Aug 19, 2022