Skip to main content
OpenTrials
Completed

NCT Number: NCT00969865

Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 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.

    Time frame: 6 month, 12 months, 18 months

Sponsors and collaborators

Lead sponsor

Piedmont Healthcare

Other

Collaborators

  • Abbott

Registry information

Acronym: iCARE

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2009
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.