Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach

Piedmont Healthcare1 site in 1 country73 target enrollmentJanuary 2009

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Piedmont Healthcare
Enrollment: 73
Locations: 1
Primary Endpoint: The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

July 2013

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Piedmont Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males between ages 35-90 or females between ages 40-90
•No known coronary artery disease
•no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
•no prior myocardial infarction
•no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
•no prior non-ST-elevation myocardial infarction (CK-MB \> 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
•no prior coronary revascularization procedure
•Aymptomatic
•no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
•Presence of a high-risk feature (at least one of the following four will quality)

Exclusion Criteria

•Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
•Creatinine 1.5 mg/dL or greater
•Irregular rhythm precluding cardiac CT examination
•Uncontrolled hypertension (SBP\>210 mmHg or DBP\>140 mmHg on treatment)
•Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
•Known Pregnancy
•Unwilling or unable to consent
•Presence of any co-morbidity that makes life expectancy less than 24 months
•Unwilling or unable to complete follow-up
•Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI

Outcomes

Primary Outcomes

The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.

Time Frame: 6 months, 1 year