Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

Atherosclerosis Clinical Trial

— iCARE  

Official title:

Individualized Comprehensive Atherosclerosis Risk-reduction Evaluation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969865
• Other study ID #: iCARE
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: November 16, 2017
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: Piedmont Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Piedmont Healthcare	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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