An Observational Study of Cholesterol in Coronary Arteries
- Conditions
- Myocardial InfarctionAnginaCoronary Artery DiseaseMyocardial Ischemia
- Interventions
- Device: Intravascular Near Infrared Spectroscopy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2067
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LipiScan Intravascular Near Infrared Spectroscopy Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
- 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)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
University of Florida, Gainesville
🇺🇸Gainesville, Florida, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
University of California Irvine Medical Center
🇺🇸Orange, California, United States
Pepin Heart Hospital
🇺🇸Tampa, Florida, United States
Medical University of South Carolina Hospital
🇺🇸Charleston, South Carolina, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Pinnacle Heart & Vascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Columbia Universtiy Medical Center
🇺🇸New York, New York, United States
University of California, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
San Francisco Veterans Affairs Medical Center
🇺🇸San Francisco, California, United States
Crittenton Shelton Heart Center:
🇺🇸Rochester Hills, Michigan, United States
Veterans Affairs, North Texas Health Care Systems
🇺🇸Dallas, Texas, United States