Coronary Artery Disease (CAD)SUSPECTNCT05508893
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
A study testing CT Angiography and Exercise stress test in people with Coronary Artery Disease (CAD) and Coronary Artery Calcification, run by UMC Utrecht at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases
- What is being tested?
- CT Angiography and Exercise stress test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesNetherlands
- Study dates
- 17 Nov 2014to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Military aircrew of the Royal Netherlands Air Force
- ≥ 40 years old
- Required to undergo cardiac screening (per military aviation regulations)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Center for Man in Aviation
Soesterberg, Utrecht, 3769 DE
Utrecht University Medical Center
Utrecht, 3584 CX
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases, Aviator's; Disease
- Being tested
- CT Angiography, Exercise stress test
- Medical subject headings
- Coronary Artery Disease, Occupational Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT AngiographyRadiation
A CTA will be performed on asymptomatic individuals
Exercise stress testDiagnostic test
A routine exercise stress test will be performed on a bicycle
| Study group | Role | What they receive |
|---|---|---|
| CT Angiography | Other | Coronary CT Angiography will be performed on all individuals Receives: Radiation: CT Angiography |
| Exercise stress test | Other | An bicycle exercise stress test will be performed on all individuals Receives: Diagnostic Test: Exercise stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
Measured: 8 Years
Secondary outcomes (4)
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%.
Measured: 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
Measured: 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
Measured: 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
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start17 Nov 2014
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Why it stopped: Funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Every participant will perform an exercise test and receive a CTA afterwards
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Man in Aviation, Royal Netherlands Air Force
- Responsible party
- Principal investigator, Erik Frijters, UMC Utrecht
- Investigators
- Hendrik Nathoe, PhD, Principal investigator, UMC UtrechtErik Frijters, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508893
- Sponsor's protocol ID
- 13-693/D
- Acronym
- SUSPECT
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40550709
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Coronary Artery Disease USing Primary Evaluation With Coronary Computed Tomography Angiography (CCTA) in Aviation Medicine (SUSPECT)
- ClinicalTrials.gov ID
- NCT05508893
- Acronym / sponsor ID
- SUSPECT / 13-693/D
- Conditions
- Coronary Artery Disease (CAD), Coronary Artery Calcification, Occupational Diseases, Aviator's; Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding stopped
- Enrolment
- 250 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Center for Man in Aviation, Royal Netherlands Air Force
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Every participant will perform an exercise test and receive a CTA afterwards
| Arm | Type | Receives |
|---|---|---|
| CT Angiography | Other | Radiation: CT AngiographyCoronary CT Angiography will be performed on all individuals |
| Exercise stress test | Other | Diagnostic Test: Exercise stress testAn bicycle exercise stress test will be performed on all individuals |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Military aircrew of the Royal Netherlands Air Force
- ≥ 40 years old
- Required to undergo cardiac screening (per military aviation regulations)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT AngiographyA CTA will be performed on asymptomatic individuals | Radiation | CT Angiography |
| Exercise stress testA routine exercise stress test will be performed on a bicycle | Diagnostic test | Exercise stress test |
Primary outcome
Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool
Time frame: 8 Years
4 secondary outcomes
Determine the diagnostic accuracy of clinically relevant CAD of the exercise stress test versus CCTA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 Years
Results and safety
The study was stopped early (reason given: Funding stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 40550709Frijters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Nathoe, PhD principal investigator
UMC Utrecht
Erik Frijters principal investigator
UMC Utrecht
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Angiography and Exercise stress test in people with Coronary Artery Disease (CAD) and Coronary Artery Calcification, run by UMC Utrecht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool (time frame: 8 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.