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

January 27, 2009
June 23, 2014
February 2009
February 2015   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00831116 on ClinicalTrials.gov Archive Site
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 ]
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An Observational Study of Cholesterol in Coronary Arteries
Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.

  • Myocardial Infarction
  • Angina
  • Coronary Artery Disease
  • Myocardial Ischemia
Device: Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Other Name: LipiScan Coronary Imaging System
LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
Intervention: Device: Intravascular Near Infrared Spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
February 2016
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Priti Shah 1-888-680-7339 ext 646 pshah@infraredx.com
United States
 
NCT00831116
0111
Yes
InfraReDx
InfraReDx
Not Provided
Study Chair: Giora Weisz, MD Columbia University
InfraReDx
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP