Clinical trial NCT00831116: An Observational Study of Cholesterol in Coronary Arteries
Official title: Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Angina
Coronary Artery Disease
Myocardial Ischemia
Keywords: near infrared spectroscopy
LipiScan
lipid core
percutaneous coronary intervention
myocardial infarction
NIRS
intravascular imaging
Lead sponsor: Infraredx
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 2067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population
timeFrame: after completion of the study - during data analysis
Secondary outcomes:
measure: Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event
timeFrame: Upto 2 years post procedure(baseline)
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida, Gainesville
state: Florida
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Rochester Hills
country: United States
facility: Crittenton Shelton Heart Center:
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia Universtiy Medical Center
state: New York
city: Harrisburg
country: United States
facility: Pinnacle Heart & Vascular Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Dallas
country: United States
facility: Veterans Affairs, North Texas Health Care Systems
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Columbia University
name: Giora Weisz, MD
role: STUDY_CHAIR
References: