An Observational Study of Cholesterol in Coronary Arteries (COLOR)

This study is currently recruiting participants.
Verified September 2013 by InfraReDx
Sponsor:
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00831116
First received: January 27, 2009
Last updated: September 17, 2013
Last verified: September 2013
  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: December 2015
Estimated Primary Completion Date: December 2013 (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
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 Recruiting
Gilbert, Arizona, United States, 85297
Contact: Stephanie Wells    480-728-9978    stephanie.wells@chw.edu   
Contact: Ann Cambpell, RN, BSN    480-728-7086    ann.campbell@chw.edu   
Principal Investigator: Nabil Dib, MD         
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Joann Saczynski, RN, MSN       jsaczynski@shc.org   
Principal Investigator: David Rizik, MD         
United States, California
University of California, Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Ladda Douangvila    310-794-4797    ldouangvila@mednet.ucla.edu   
Principal Investigator: Jon Tobis, MD         
University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Beth Michel, RN       emichel@uci.edu   
Principal Investigator: Pranav Patel, MD         
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Kathleen Stanley, RN    415-221-4810 ext 4220    kathleen.stanley@va.gov   
Principal Investigator: Kendrick Shunk, MD,PhD         
United States, Florida
University of Florida, Gainesville Recruiting
Gainesville, Florida, United States, 32610
Contact: Sarah Long, RN       sarah.long@medicine.ufl.edu   
Contact: Dana Leach, RN       dana.leach@medicine.ufl.edu   
Principal Investigator: Carl J Pepine, MD         
Pepin Heart Hospital Recruiting
Tampa, Florida, United States, 33613
Contact: Abigail Snow       Abigail.Snow@AHSS.ORG   
Principal Investigator: Charles Lambert         
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Laura Murrieta, BS,RD    404-605-3074    laura.murrieta@piedmont.org   
Principal Investigator: William L Ballard, MD         
United States, Maryland
Washington Adventist Hospital Recruiting
Takoma Park, Maryland, United States, 20912
Contact: Dawn E Shaddinger, RN, MSN    301-891-5612    dshaddin@adventisthealthcare.com   
Contact: Denise Pond, RN       dpond@ahm.com   
Principal Investigator: Fayaz Shawl, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Kaufman, RN       jmkaufma@bidmc.harvard.edu   
Principal Investigator: Donald Cutlip, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Iris McNulty, RN    617-726-2612    imcnulty@partners.org   
Principal Investigator: Ik-Kyung Jang, MD, PhD         
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01803
Contact: Judy Pendleton    781-744-7512    Judy.E.Pendleton@lahey.org   
Principal Investigator: Thomas Piemonte         
United States, Michigan
Crittenton Shelton Heart Center: Recruiting
Rochester Hills, Michigan, United States, 48307
Contact: Elias H, Boueiri    248-652-5156    eboueiri@Crittenton.com   
Principal Investigator: Samer Kazziha         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Dorothy Richardson    248-898-9161    drichardson@beaumont.edu   
Principal Investigator: Simon R Dixon, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy M Woltman, RN    507-266-4095    woltman.cindy@mayo.edu   
Principal Investigator: Amir Lerman, MD         
United States, Missouri
Saint Louis University Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Elizabeth Weber, RN, MSN    314-577-8876    eweber1@slu.edu   
Contact: Christine Uhles, RN, BSN    314-577-8876    ctaaffe1@slu.edu   
Principal Investigator: Michael J Lim, MD         
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Carolina Capunay       carolina.capunay@mountsinai.org   
Principal Investigator: Annapoorna S Kini, MD         
Sub-Investigator: Pedro Moreno, MD         
Columbia Universtiy Medical Center Recruiting
New York, New York, United States, 10032
Contact: Luz Jaquez       lj2282@columbia.edu   
Principal Investigator: Giora Weisz, MD         
United States, Pennsylvania
Pinnacle Heart & Vascular Institute Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Debra Cassatt       dcassatt@pinnaclehealth.org   
Principal Investigator: Brijeshwar Maini, MD         
United States, South Carolina
Medical University of South Carolina Hospital Recruiting
Charleston, South Carolina, United States, 29403
Contact: Michelle lincoln, RN       lincolnm@musc.edu   
Principal Investigator: Eric R Powers, MD         
United States, Texas
Veterans Affairs, North Texas Health Care Systems Recruiting
Dallas, Texas, United States, 75216
Contact: Katherine Harper       Katherine.Harper@va.gov   
Principal Investigator: Emmanouil S Brilakis, MD,PhD         
Sub-Investigator: Subhash Banerjee, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Jennifer Nagel    206-386-6462    jennifer.nagel@swedish.org   
Principal Investigator: John L Petersen, MD         
Principal Investigator: Mark Reisman, MD         
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: September 17, 2013
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
Myocardial Ischemia
Coronary Disease
Infarction
Ischemia
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 17, 2014