Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program (iCARE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Piedmont Healthcare
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Piedmont Healthcare
ClinicalTrials.gov Identifier:
NCT00969865
First received: August 31, 2009
Last updated: April 14, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Piedmont Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: July 2014 (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.
Standard Management Group
Participants who receive standard of care.

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
Study Population

Individuals with no known coronary artery disease and who have an intermediate or high Framingham Risk Score (10 year risk 10 percent or greater).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969865

Contacts
Contact: Nancy Flockhart 404-605-2875 nancy.flockhart@piedmont.org
Contact: Joseph Miller, MD 404-605-2800 joseph.miller@piedmont.org

Locations
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         
Sponsors and Collaborators
Piedmont Healthcare
Abbott
Investigators
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: April 14, 2014
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 July 28, 2014