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 Overview

• Status: Completed
• Conditions: Atherosclerosis

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.

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	6 months, 12 months, 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	6 month, 12 months, 18 months

Collaborators and Investigators

• Sponsor: Piedmont Healthcare
• Collaborators: Abbott
• Investigators: Principal Investigator: Joseph Miller, MD, Piedmont Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Atherosclerosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: iCARE