Status:
COMPLETED
Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
Lead Sponsor:
Piedmont Healthcare
Collaborating Sponsors:
Abbott
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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, parti...
Detailed Description
The purpose of this proposal is to create a large, community-based demonstration project to evaluate the value of a highly individualized approach to atherosclerosis risk reduction. In this project we...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00969865
Start Date
October 1 2011
End Date
December 1 2016
Last Update
November 20 2017
Active Locations (1)
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1
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309