An Observational Study of Cholesterol in Coronary Arteries (COLOR)

Tracking Information
First Submitted Date	January 27, 2009
First Posted Date	January 28, 2009
Last Update Posted Date	June 9, 2017
Actual Study Start Date	February 2009
Actual Primary Completion Date	February 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: March 25, 2013)	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 ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00831116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: March 25, 2013)	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) ]
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	An Observational Study of Cholesterol in Coronary Arteries
Official Title	Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	Myocardial Infarction; Angina; Coronary Artery Disease; Myocardial Ischemia
Intervention	Device: Intravascular Near Infrared Spectroscopy; Intravascular imaging with a catheter based spectroscopy system.; Other Name: LipiScan Coronary Imaging System
Study Groups/Cohorts	LipiScan; Subjects who have at least one native coronary artery imaged with the LipiScan CIS.; Intervention: Device: Intravascular Near Infrared Spectroscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: August 29, 2016)	2067
Original Estimated Enrollment; (submitted: January 27, 2009)	1000
Actual Study Completion Date	April 2017
Actual Primary Completion Date	February 2016 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00831116
Other Study ID Numbers	0111
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	InfraReDx
Study Sponsor	InfraReDx
Collaborators	Not Provided
Investigators	Study Chair: Giora Weisz, MD Columbia University
PRS Account	InfraReDx
Verification Date	June 2017