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Screening for coronary artery disease using primary evaluation with coronary CTA in aviation medicine

Completed
Conditions
coronary artery disease
10011082
Registration Number
NL-OMON40436
Lead Sponsor
Centrum voor Mens en Luchtvaart / Koninklijke Luchtmacht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
250
Inclusion Criteria

- Military aircrew of the Royal Netherlands Airforce
- >= 40 years old.
- Required to undergo cardiac screening at the Centre for Man and Aviation (Centrum voor Mens en Luchtvaart (CML))

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 unwilling or unable to comply to study procedures
- Prior allergic reaction 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

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>a. Clinically significant CAD, defined as a stenosis >= 50%<br /><br>b. Clinically non-significant CAD, defined as a stenosis 30%-49%</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. To determine the diagnostic accuracy of the exercise stress test for:<br /><br>a. Clinically significant CAD, defined as a stenosis >= 50%<br /><br>b. Clinically non-significant CAD, defined as a stenosis 30%-49%<br /><br><br /><br>2. To compare the incidence of coronary angiograms and coronary<br /><br>revascularization procedures (i.e. PCI or CABG procedures) in the population<br /><br>screened with CTA compared to a historical population using CTA as a secondary<br /><br>screening tool<br /><br><br /><br>3. To establish the additive value of CACS in addition to clinical risk scores<br /><br>(European Society of heart Score or Framingham) as a predictor of CAD on CCTA.</p><br>
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