Angina, Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia
Conditions
Keywords
near infrared spectroscopy, LipiScan, lipid core, percutaneous coronary intervention, myocardial infarction, NIRS, intravascular imaging
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.
Interventions
DEVICEIntravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Sponsors
Infraredx
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
United States
Outcome results
None listed