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

Coronary Artery Disease (CAD) Clinical Trial

— SUSPECT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05508893
• Other study ID #: 13-693/D
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Calcification
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Disease
• Myocardial Ischemia
• Occupational Diseases

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