Coronary Artery Disease Clinical Trial
— COLOROfficial title:
Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
Verified date | June 2017 |
Source | InfraReDx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2067 |
Est. completion date | April 2017 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Lahey Clinic | Burlington | Massachusetts |
United States | Medical University of South Carolina Hospital | Charleston | South Carolina |
United States | Veterans Affairs, North Texas Health Care Systems | Dallas | Texas |
United States | University of Florida, Gainesville | Gainesville | Florida |
United States | Mercy Gilbert Medical Center | Gilbert | Arizona |
United States | Pinnacle Heart & Vascular Institute | Harrisburg | Pennsylvania |
United States | University of California, Los Angeles Medical Center | Los Angeles | California |
United States | Columbia Universtiy Medical Center | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | University of California Irvine Medical Center | Orange | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Crittenton Shelton Heart Center: | Rochester Hills | Michigan |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Saint Louis University Hospital | Saint Louis | Missouri |
United States | San Francisco Veterans Affairs Medical Center | San Francisco | California |
United States | Scottsdale Healthcare | Scottsdale | Arizona |
United States | Swedish Medical Center | Seattle | Washington |
United States | Washington Adventist Hospital | Takoma Park | Maryland |
United States | Pepin Heart Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
InfraReDx |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
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