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An Observational Study of Cholesterol in Coronary Arteries (COLOR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00831116
First received: January 27, 2009
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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 Intervention
Myocardial Infarction
Angina
Coronary Artery Disease
Myocardial Ischemia
Device: Intravascular Near Infrared Spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

Resource links provided by NLM:


Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Enrollment: 2067
Study Start Date: February 2009
Estimated Study Completion Date: November 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: LipiScan Coronary Imaging System

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831116

Locations
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
St. 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
InfraReDx
Investigators
Study Chair: Giora Weisz, MD Columbia University
  More Information

Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT00831116     History of Changes
Other Study ID Numbers: 0111 
Study First Received: January 27, 2009
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 23, 2016