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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05508893
Other study ID # 13-693/D
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 17, 2014
Est. completion date June 21, 2022

Study information

Verified date August 2022
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 aeromedical examination. Coronary Artery Calcium score (CACS) and CCTA findings are reported.


Recruitment information / eligibility

Status Terminated
Enrollment 250
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

Radiation:
CT Angiography
A CTA will be performed on asymptomatic individuals
Diagnostic Test:
Exercise stress test
A routine exercise stress test will be performed on a bicycle

Locations

Country Name City State
Netherlands Center for Man in Aviation Soesterberg Utrecht
Netherlands Utrecht University Medical Center Utrecht

Sponsors (2)

Lead Sponsor Collaborator
UMC Utrecht Center for Man in Aviation, Royal Netherlands Air Force

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the prevalence and severity of CAD in asymptomatic air crew using CCTA as a primary screening tool 8 Years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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