NCT05508893

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

7.6 years

First QC Date

August 9, 2022

Last Update Submit

August 23, 2022

Conditions

Coronary Artery Disease (CAD)Coronary Artery CalcificationOccupational DiseasesAviator's; Disease

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool

    8 Years

Secondary Outcomes (4)

  • Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA

    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

Study Arms (2)

CT Angiography

OTHER

Coronary CT Angiography will be performed on all individuals

Radiation: CT Angiography

Exercise stress test

OTHER

An bicycle exercise stress test will be performed on all individuals

Diagnostic Test: Exercise stress test

Interventions

CT AngiographyRADIATION

A CTA will be performed on asymptomatic individuals

CT Angiography
Exercise stress testDIAGNOSTIC_TEST

A routine exercise stress test will be performed on a bicycle

Exercise stress test

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Military aircrew of the Royal Netherlands Air Force
  • ≥ 40 years old
  • Required to undergo cardiac screening (per military aviation regulations)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Man in Aviation

Soesterberg, Utrecht, 3769 DE, Netherlands

Location

Utrecht University Medical Center

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • Frijters E, Nathoe H, Grobben R, Broekhuizen L, Rienks R, Velthuis B. Prevalence and severity of coronary artery disease in asymptomatic military air crew in the Netherlands: a prospective, cross-sectional study (SUSPECT). BMJ Open. 2025 Jun 23;15(6):e100250. doi: 10.1136/bmjopen-2025-100250.

    PMID: 40550709DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseOccupational DiseasesDisease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Hendrik Nathoe, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

  • Erik Frijters

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Every participant will perform an exercise test and receive a CTA afterwards
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 19, 2022

Study Start

November 17, 2014

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)