An Observational Study of Cholesterol in Coronary Arteries

NCT ID: NCT00831116

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2067 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2017-04-30

Brief Summary

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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

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Conditions

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Myocardial Infarction Angina Coronary Artery Disease Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LipiScan

Subjects who have at least one native coronary artery imaged with the LipiScan CIS.

Intravascular Near Infrared Spectroscopy

Intervention Type DEVICE

Intravascular imaging with a catheter based spectroscopy system.

Interventions

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Intravascular Near Infrared Spectroscopy

Intravascular imaging with a catheter based spectroscopy system.

Intervention Type DEVICE

Other Intervention Names

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LipiScan Coronary Imaging System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Infraredx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giora Weisz, MD

Role: STUDY_CHAIR

Columbia University

Locations

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Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Site Status

Scottsdale Healthcare

Scottsdale, Arizona, United States

Site Status

University of California, Los Angeles Medical Center

Los Angeles, California, United States

Site Status

University of California Irvine Medical Center

Orange, California, United States

Site Status

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Site Status

University of Florida, Gainesville

Gainesville, Florida, United States

Site Status

Pepin Heart Hospital

Tampa, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Washington Adventist Hospital

Takoma Park, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Crittenton Shelton Heart Center:

Rochester Hills, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Saint Louis University Hospital

St Louis, Missouri, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Columbia Universtiy Medical Center

New York, New York, United States

Site Status

Pinnacle Heart & Vascular Institute

Harrisburg, Pennsylvania, United States

Site Status

Medical University of South Carolina Hospital

Charleston, South Carolina, United States

Site Status

Veterans Affairs, North Texas Health Care Systems

Dallas, Texas, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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0111

Identifier Type: -

Identifier Source: org_study_id

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