Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program (iCARE)
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).
|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 ]
|Study Start Date:||October 2011|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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.
Standard Management Group
Participants who receive standard of care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969865
|Contact: Nancy Flockhartfirstname.lastname@example.org|
|Contact: Joseph Miller, MDemail@example.com|
|United States, Georgia|
|Piedmont Heart Institute||Recruiting|
|Atlanta, Georgia, United States, 30309|
|Contact: Nancy Flockhart 404-605-2875 firstname.lastname@example.org|
|Contact: Shan Liu 404-605-4098 email@example.com|
|Principal Investigator: Joseph Miller, MD|
|Principal Investigator:||Joseph Miller, MD||Piedmont Heart Institute|