An Observational Study of Cholesterol in Coronary Arteries

Completed

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

In brief

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.

Key facts

Study ID

NCT00831116

Run by

Infraredx

People needed

2067

Starts

2009-02-01

Expected to finish

2017-04-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Crittenton Shelton Heart Center: — Rochester Hills, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University Hospital — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia Universtiy Medical Center — New York, New York, United States
• Pinnacle Heart & Vascular Institute — Harrisburg, Pennsylvania, United States
• Medical University of South Carolina Hospital — Charleston, South Carolina, United States
• Veterans Affairs, North Texas Health Care Systems — Dallas, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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