An Observational Study of Cholesterol in Coronary Arteries

Study Overview
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Brief Summary
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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.

Official Title
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Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

Conditions
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Myocardial Infarction, Angina, Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
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* Device: Intravascular Near Infrared Spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LipiScan<br>Subjects who have at least one native coronary artery imaged with the LipiScan CIS. | Device: Intravascular Near Infrared Spectroscopy<br>* Intravascular imaging with a catheter based spectroscopy system.<br>* Other names: LipiScan Coronary Imaging System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near infrared spectroscopy, LipiScan, lipid core, percutaneous coronary intervention, myocardial infarction, NIRS, intravascular imaging