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Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

NCT ID: NCT00969865

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Atherosclerosis

Keywords

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Atherosclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Standard Management Group

Participants who receive standard of care.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Piedmont Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Locations

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Piedmont Heart Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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iCARE

Identifier Type: -

Identifier Source: org_study_id