An Observational Study of Cholesterol in Coronary Arteries (COLOR)

June 8, 2017 updated by: Infraredx

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2067

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Mercy Gilbert Medical Center
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Healthcare
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida, Gainesville
      • Tampa, Florida, United States, 33613
        • Pepin Heart Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Maryland
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01803
        • Lahey Clinic
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Crittenton Shelton Heart Center:
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10032
        • Columbia Universtiy Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Pinnacle Heart & Vascular Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina Hospital
    • Texas
      • Dallas, Texas, United States, 75216
        • Veterans Affairs, North Texas Health Care Systems
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
Device: Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Other Names:
  • LipiScan Coronary Imaging System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after completion of the study - during data analysis

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Upto 2 years post procedure(baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infraredx

Investigators

  • Study Chair: Giora Weisz, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2009

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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