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An Observational Study of Cholesterol in Coronary Arteries (COLOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00831116
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Myocardial Infarction Angina Coronary Artery Disease Myocardial Ischemia Device: Intravascular Near Infrared Spectroscopy

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Study Type : Observational
Actual Enrollment : 2067 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
Actual Study Start Date : February 2009
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2017

Group/Cohort Intervention/treatment
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 Name: LipiScan Coronary Imaging System

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00831116

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

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Responsible Party: InfraReDx Identifier: NCT00831116     History of Changes
Other Study ID Numbers: 0111
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by InfraReDx:
near infrared spectroscopy
lipid core
percutaneous coronary intervention
myocardial infarction
intravascular imaging

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases