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Detection of Subclinical Atherosclerosis in Asymptomatic Individuals | Clinical Trials | Clareo Health

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Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

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

NCT00862056•Piedmont Healthcare

View on ClinicalTrials.gov

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.

Eligibility

Age

35 - 90 years

Sex

ALL

Healthy Volunteers

Yes

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)
+9 more criteria

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

Locations (1)

Piedmont Hospital

Atlanta, Georgia, United States

Key Dates

Start Date

January 1, 2009

Primary Completion Date

July 1, 2013

Completion Date

July 1, 2013

Last Updated

November 20, 2017

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

Cardiac CT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

Inclusion Criteria

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