Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

NCT00969865 | Completed

• 1 other identifier: iCARE
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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, 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).

Conditions

Atherosclerosis

Keywords

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Presence of known cardiomyopathy
• Presence of permanent pacemaker, defibrillator, or CRT device
• 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

Sponsors & Collaborators

• Piedmont Healthcare: lead
• Abbott: collaborator

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joseph Miller, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 1, 2009
• Study Start: October 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

US (1)