An Observational Study of Cholesterol in Coronary Arteries (COLOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by InfraReDx
Sponsor:
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00831116
First received: January 27, 2009
Last updated: June 23, 2014
Last verified: June 2014
  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 ]

Estimated Enrollment: 2000
Study Start Date: February 2009
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (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
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

Contacts
Contact: Priti Shah 1-888-680-7339 ext 646 pshah@infraredx.com

Locations
United States, Arizona
Mercy Gilbert Medical Center Active, not recruiting
Gilbert, Arizona, United States, 85297
Scottsdale Healthcare Active, not recruiting
Scottsdale, Arizona, United States, 85260
United States, California
University of California, Los Angeles Medical Center Active, not recruiting
Los Angeles, California, United States, 90095
University of California Irvine Medical Center Active, not recruiting
Orange, California, United States, 92868
San Francisco Veterans Affairs Medical Center Active, not recruiting
San Francisco, California, United States, 94121
United States, Florida
University of Florida, Gainesville Active, not recruiting
Gainesville, Florida, United States, 32610
Pepin Heart Hospital Active, not recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Piedmont Hospital Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Maryland
Washington Adventist Hospital Active, not recruiting
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Beth Israel Deaconess Medical Center Completed
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02115
Lahey Clinic Active, not recruiting
Burlington, Massachusetts, United States, 01803
United States, Michigan
Crittenton Shelton Heart Center: Active, not recruiting
Rochester Hills, Michigan, United States, 48307
William Beaumont Hospital Active, not recruiting
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis University Hospital Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Adam Asif       asif.adam@mountsinai.org   
Principal Investigator: Annapoorna S Kini, MD         
Sub-Investigator: Pedro Moreno, MD         
Columbia Universtiy Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, Pennsylvania
Pinnacle Heart & Vascular Institute Active, not recruiting
Harrisburg, Pennsylvania, United States, 17101
United States, South Carolina
Medical University of South Carolina Hospital Active, not recruiting
Charleston, South Carolina, United States, 29403
United States, Texas
Veterans Affairs, North Texas Health Care Systems Active, not recruiting
Dallas, Texas, United States, 75216
United States, Washington
Swedish Medical Center Active, not recruiting
Seattle, Washington, United States, 98122
Sponsors and Collaborators
InfraReDx
Investigators
Study Chair: Giora Weisz, MD Columbia University
  More Information

No publications provided

Responsible Party: InfraReDx
ClinicalTrials.gov Identifier: NCT00831116     History of Changes
Other Study ID Numbers: 0111
Study First Received: January 27, 2009
Last Updated: June 23, 2014
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:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014