This trial is active, not recruiting.

Conditions myocardial infarction, angina, coronary artery disease, myocardial ischemia
Treatment intravascular near infrared spectroscopy
Sponsor InfraReDx
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

Study Design

Observational model cohort
Time perspective prospective
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
intravascular near infrared spectroscopy LipiScan Coronary Imaging System
Intravascular imaging with a catheter based spectroscopy system.

Primary Outcomes

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

Secondary Outcomes

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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by InfraReDx.