An Observational Study of Cholesterol in Coronary Arteries

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.

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Key information

Conditions

Myocardial Infarction Angina Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mercy Gilbert Medical Center, Gilbert, Arizona, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intravascular Near Infrared Spectroscopy

Device

Intravascular imaging with a catheter based spectroscopy system.

Other names: LipiScan Coronary Imaging System

Primary outcomes

Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population

Time frame: after completion of the study - during data analysis

Secondary outcomes

Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event

Time frame: Upto 2 years post procedure(baseline)

Sponsors and collaborators

Lead sponsor

Infraredx

Industry

Registry information

Official study title

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

Acronym: COLOR

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2017
First posted: Jan 28, 2009
Registry last updated: Jun 9, 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.

Completed