An Observational Study of Cholesterol in Coronary Arteries
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Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
1 other identifier
observational
2,067
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2009
CompletedFirst Posted
Study publicly available on registry
January 28, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJune 9, 2017
June 1, 2017
7 years
January 27, 2009
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Study Arms (1)
LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
Interventions
Intravascular imaging with a catheter based spectroscopy system.
Eligibility Criteria
Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Infraredxlead
Study Sites (22)
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85260, United States
University of California, Los Angeles Medical Center
Los Angeles, California, 90095, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121, United States
University of Florida, Gainesville
Gainesville, Florida, 32610, United States
Pepin Heart Hospital
Tampa, Florida, 33613, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic
Burlington, Massachusetts, 01803, United States
Crittenton Shelton Heart Center:
Rochester Hills, Michigan, 48307, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia Universtiy Medical Center
New York, New York, 10032, United States
Pinnacle Heart & Vascular Institute
Harrisburg, Pennsylvania, 17101, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, 29403, United States
Veterans Affairs, North Texas Health Care Systems
Dallas, Texas, 75216, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giora Weisz, MD
Columbia University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2009
First Posted
January 28, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2016
Study Completion
April 1, 2017
Last Updated
June 9, 2017
Record last verified: 2017-06