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Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Intravascular Near Infrared Spectroscopy to evaluate Myocardial Infarction, Angina, Coronary Artery Disease or Myocardial Ischemia

Research Study Title

Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry

Purpose

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.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

InfraReDx

Duration

72 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
United States New York New York 10029 Mount Sinai School of Medicine
Adam Asif
asif.adam@mountsinai.org

Annapoorna S Kini, MD
Principal Investigator

Pedro Moreno, MD
Sub-Investigator

Contact

Priti Shah
1-888-680-7339 ext. 646

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT00831116

Date Last Changed: June 23, 2014

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