Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program (iCARE)
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Purpose
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).
| Condition |
|---|
|
Atherosclerosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program |
- To determine the proportion of subjects and patients who are diagnosed with subclinical and clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach. [ Time Frame: 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
- To determine the proportion of patients who receive appropriate revascularization procedures for clinically significant coronary atherosclerosis with the PHI-ACE-iCARE approach, compared to the current guideline-driven approach. [ Time Frame: 6 month, 12 months, 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 670 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Individualized Managment Group
Participants receiving, in addition to standard of care, blood tests for markers of heart disease, DNA and RNA analysis, and coronary artery calcium scan.
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Standard Management Group
Participants who receive standard of care.
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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 set out to compare the delivery of appropriate therapies and resource utilization using current national guidelines for the management of atherosclerosis and will compare this to using a highly individualized approach for atherosclerosis risk reduction, based on the evaluation of specific features in individuals and tailoring management based on this evaluation. We plan to show that utilizing the iCARE Program, more patients will receive appropriate diagnoses and subsequent therapies in a more efficient manner.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Individuals with no known coronary artery disease and who have an intermediate or high Framingham Risk Score (10 year risk 10 percent or greater).
Inclusion Criteria:
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 Criteria:
- 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
Contacts and Locations| Contact: Nancy Flockhart | 404-605-2875 | nancy.flockhart@piedmont.org |
| Contact: Joseph Miller, MD | 404-605-2800 | joseph.miller@piedmont.org |
| United States, Georgia | |
| Piedmont Heart Institute | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Nancy Flockhart 404-605-2875 nancy.flockhart@piedmont.org | |
| Contact: Shan Liu 404-605-4098 shan.liu@piedmont.org | |
| Principal Investigator: Joseph Miller, MD | |
| Principal Investigator: | Joseph Miller, MD | Piedmont Heart Institute |
More Information
No publications provided
| Responsible Party: | Piedmont Healthcare |
| ClinicalTrials.gov Identifier: | NCT00969865 History of Changes |
| Other Study ID Numbers: | iCARE |
| Study First Received: | August 31, 2009 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Piedmont Healthcare:
|
Atherosclerosis |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013