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COLOR: An Observational Study of Cholesterol in Coronary Arteries

Sponsor
Infraredx (Industry)
Overall Status
Completed
CT.gov ID
NCT00831116
Collaborator
(none)
2,067
Enrollment
22
Locations
97.9
Actual Duration (Months)
94
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Intravascular Near Infrared Spectroscopy

Study Design

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 :
Feb 1, 2009
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • LipiScan Coronary Imaging System

    		•

    Outcome Measures

    Primary Outcome Measures

    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 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 [Upto 2 years post procedure(baseline)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Mercy Gilbert Medical Center Gilbert Arizona United States 85297
    2 Scottsdale Healthcare Scottsdale Arizona United States 85260
    3 University of California, Los Angeles Medical Center Los Angeles California United States 90095
    4 University of California Irvine Medical Center Orange California United States 92868
    5 San Francisco Veterans Affairs Medical Center San Francisco California United States 94121
    6 University of Florida, Gainesville Gainesville Florida United States 32610
    7 Pepin Heart Hospital Tampa Florida United States 33613
    8 Piedmont Hospital Atlanta Georgia United States 30309
    9 Washington Adventist Hospital Takoma Park Maryland United States 20912
    10 Massachusetts General Hospital Boston Massachusetts United States 02115
    11 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    12 Lahey Clinic Burlington Massachusetts United States 01803
    13 Crittenton Shelton Heart Center: Rochester Hills Michigan United States 48307
    14 William Beaumont Hospital Royal Oak Michigan United States 48073
    15 Mayo Clinic Rochester Minnesota United States 55905
    16 Saint Louis University Hospital Saint Louis Missouri United States 63110
    17 Mount Sinai School of Medicine New York New York United States 10029
    18 Columbia Universtiy Medical Center New York New York United States 10032
    19 Pinnacle Heart & Vascular Institute Harrisburg Pennsylvania United States 17101
    20 Medical University of South Carolina Hospital Charleston South Carolina United States 29403
    21 Veterans Affairs, North Texas Health Care Systems Dallas Texas United States 75216
    22 Swedish Medical Center Seattle Washington United States 98122

    Sponsors and Collaborators

    • Infraredx

    Investigators

    • Study Chair: Giora Weisz, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Infraredx
    ClinicalTrials.gov Identifier:
    NCT00831116
    Other Study ID Numbers:
    • 0111
    First Posted:
    Jan 28, 2009
    Last Update Posted:
    Jun 9, 2017
    Last Verified:
    Jun 1, 2017
    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
    Myocardial Infarction
    Infarction
    Ischemia

    Study Results

    No Results Posted as of Jun 9, 2017