An Observational Study of Cholesterol in Coronary Arteries (COLOR)

Infraredx

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Angina

Treatments: Device: Intravascular Near Infrared Spectroscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT00831116

0111

Details and patient eligibility

About

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.

Enrollment: 2,067 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,067 participants in 1 patient group

LipiScan

Description:

Subjects who have at least one native coronary artery imaged with the LipiScan CIS.

Treatment:

Device: Intravascular Near Infrared Spectroscopy