An Observational Study of Cholesterol in Coronary Arteries

Coronary Artery Disease Clinical Trial

— COLOR  

Official title:

Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831116
• Other study ID #: 0111
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: June 8, 2017
• Start date: February 2009
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: InfraReDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2067
• Est. completion date: April 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is at least 18 years of age.

• Subject is scheduled for elective coronary catheterization.

• LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.

• At least one chemogram from a native coronary artery is available for submission to the registry.

• Able to read, understand and sign the informed consent.

Exclusion Criteria:

• Subject is pregnant or nursing.

• Subject life expectancy is less than 2 years at time of index catheterization.

• All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.

• Unable to give informed consent

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Medical University of South Carolina Hospital	Charleston	South Carolina
United States	Veterans Affairs, North Texas Health Care Systems	Dallas	Texas
United States	University of Florida, Gainesville	Gainesville	Florida
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Pinnacle Heart & Vascular Institute	Harrisburg	Pennsylvania
United States	University of California, Los Angeles Medical Center	Los Angeles	California
United States	Columbia Universtiy Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	University of California Irvine Medical Center	Orange	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Crittenton Shelton Heart Center:	Rochester Hills	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	Swedish Medical Center	Seattle	Washington
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Pepin Heart Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InfraReDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population		after completion of the study - during data analysis
Secondary	Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event		Upto 2 years post procedure(baseline)