An Observational Study of Cholesterol in Coronary Arteries (COLOR)
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|ClinicalTrials.gov Identifier: NCT00831116|
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : June 9, 2017
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|Condition or disease||Intervention/treatment|
|Myocardial Infarction Angina Coronary Artery Disease Myocardial Ischemia||Device: Intravascular Near Infrared Spectroscopy|
|Study Type :||Observational|
|Actual Enrollment :||2067 participants|
|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|
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
- 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 ]
- 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) ]
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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|
- 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.
- 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
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
|Study Chair:||Giora Weisz, MD||Columbia University|
|Other Study ID Numbers:||
|First Posted:||January 28, 2009 Key Record Dates|
|Last Update Posted:||June 9, 2017|
|Last Verified:||June 2017|
near infrared spectroscopy
percutaneous coronary intervention
Coronary Artery Disease
Arterial Occlusive Diseases