Detection of Subclinical Atherosclerosis in Asymptomatic Individuals
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 35 - 90 |
| Updated: | 11/22/2017 |
| Start Date: | January 2009 |
| End Date: | July 2013 |
Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach
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.
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.
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)
1. LDL > 250 mg/dL
2. HDL < 20 mg/dL
3. Triglycerides > 1000 mg/dL
4. 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
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