An Observational Study of Cholesterol in Coronary Arteries
This trial is active, not recruiting.
|Conditions||myocardial infarction, angina, coronary artery disease, myocardial ischemia|
|Treatment||intravascular near infrared spectroscopy|
|Start date||February 2009|
|End date||February 2016|
|Trial size||2067 participants|
|Trial identifier||NCT00831116, 0111|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Gilbert, AZ||Mercy Gilbert Medical Center||no longer recruiting|
|Scottsdale, AZ||Scottsdale Healthcare||no longer recruiting|
|Los Angeles, CA||University of California, Los Angeles Medical Center||no longer recruiting|
|Orange, CA||University of California Irvine Medical Center||no longer recruiting|
|San Francisco, CA||San Francisco Veterans Affairs Medical Center||no longer recruiting|
|Gainesville, FL||University of Florida, Gainesville||no longer recruiting|
|Tampa, FL||Pepin Heart Hospital||no longer recruiting|
|Atlanta, GA||Piedmont Hospital||no longer recruiting|
|Takoma Park, MD||Washington Adventist Hospital||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Burlington, MA||Lahey Clinic||no longer recruiting|
|Rochester Hills, MI||Crittenton Shelton Heart Center:||no longer recruiting|
|Royal Oak, MI||William Beaumont Hospital||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|St. Louis, MO||Saint Louis University Hospital||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine||no longer recruiting|
|New York, NY||Columbia Universtiy Medical Center||no longer recruiting|
|Harrisburg, PA||Pinnacle Heart & Vascular Institute||no longer recruiting|
|Charleston, SC||Medical University of South Carolina Hospital||no longer recruiting|
|Dallas, TX||Veterans Affairs, North Texas Health Care Systems||no longer recruiting|
|Seattle, WA||Swedish Medical Center||no longer recruiting|
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
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)
Male or female participants at least 18 years old.
- 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
|Official title||Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry|
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