Detection of Subclinical Atherosclerosis in Asymptomatic Individuals

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Cardiac CT


Participation Criteria
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Eligibility Criteria
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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) High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp) Diabetes Mellitus Premature CAD in a first-degree relative High Risk Lipid Profile (must meet one of the following laboratory criteria) LDL > 250 mg/dL HDL < 20 mg/dL Triglycerides > 1000 mg/dL LP(a) > 80 mg/dL Provide written informed consent and Authorization for Use/Disclosure of PHI 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac CT<br>All participants will undergo a coronary artery CT angiogram | Procedure: Cardiac CT<br>* All participants will undergo a coronary artery CT angiogram with contrast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 6 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asymptomatic, coronary artery disease