Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
Completed
Conditions studied: Atherosclerosis
In brief
This study will evaluate the effectiveness of an individualized approach to diagnosing and/or treating atherosclerosis. This will be done by combining genetic information, lifestyle information, participant education, and imaging tests to track diagnoses, therapies, and treatment on two groups: 1) Standard Management Group (diagnosed and/or treated according to standard of care) and 2) Individualized Management Group (standard of care plus genetic testing and coronary artery calcium scans).
Key facts
- Study ID
- NCT00969865
- Run by
- Piedmont Healthcare
- People needed
- 170
- Starts
- 2011-10-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- No known coronary artery disease
- no prior coronary disease by cardiac catheterization (≤39% 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
- Intermediate or high Framingham Risk Score (10-year risk 10% or greater)
- Ability and willingness to provide consent and Authorization for use of PHI
You may not qualify if…
- Presence of known cardiomyopathy
- Presence of permanent pacemaker, defibrillator, or CRT device
- Presence of clinically significant, uncontrolled arrhythmia (chronic or paroxysmal atrial fibrillation is NOT an exclusion. Arrhythmias treated successfully with ablation are not an exclusion.
- Presence of a known genetic abnormality of cholesterol metabolism (e.g. familial hypercholesterolemia)
- Inability or unwillingness to adhere to follow up schedule
- Inability or unwillingness to provide informed consent and Authorization for use of PHI
Where it is running
- Piedmont Heart Institute — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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