Clinical trial NCT00969865: Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
Official title: Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Keywords: Atherosclerosis
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2009-09-01
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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).

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 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

Primary outcomes:
measure: 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.
timeFrame: 6 months, 12 months, 18 months
Secondary outcomes:
measure: 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.
timeFrame: 6 month, 12 months, 18 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
Study officials:
affiliation: Piedmont Heart Institute
name: Joseph Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: