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An Observational Study of Cholesterol in Coronary Arteries (COLOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00831116
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Infraredx

Study Description
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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
Myocardial Infarction Angina Coronary Artery Disease Myocardial Ischemia Device: Intravascular Near Infrared Spectroscopy

Study Design
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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 : February 2009
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2017
Groups and Cohorts
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Group/Cohort 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 Name: LipiScan Coronary Imaging System


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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 [ Time Frame: Upto 2 years post procedure(baseline) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831116


Locations
Show Show 22 study locations
Sponsors and Collaborators
Infraredx
Investigators
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Study Chair: Giora Weisz, MD Columbia University
More Information
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Responsible Party: Infraredx
ClinicalTrials.gov Identifier: NCT00831116    
Other Study ID Numbers: 0111
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Keywords provided by Infraredx:
near infrared spectroscopy
LipiScan
lipid core
percutaneous coronary intervention
 myocardial infarction
NIRS
intravascular imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases