An Observational Study of Cholesterol in Coronary Arteries

Completed

• Conditions: Myocardial Infarction; Angina; Coronary Artery Disease; Myocardial Ischemia

• Registration Number: NCT00831116
• Lead Sponsor: Infraredx

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 available

Study Timeline

• Study First Submitted: 2009-01-27
• Study First Submitted QC: 2009-01-27
• Study First Posted: 2009-01-28
• Study Start: 2009-02
• Primary Completion: 2016-02
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2067

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (22)

Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Scottsdale Healthcare; 🇺🇸 Scottsdale, Arizona, United States

University of California, Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States

University of Florida, Gainesville; 🇺🇸 Gainesville, Florida, United States

Pepin Heart Hospital; 🇺🇸 Tampa, Florida, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Washington Adventist Hospital; 🇺🇸 Takoma Park, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

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