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NCT00831116 · ClinicalTrials.gov registry record

An Observational Study of Cholesterol in Coronary Arteries

A clinical trial of Coronary Artery Disease and Myocardial Infarction, sponsored by Infraredx.

Completed
Registry status
2,067
Enrollment target
20
Study locations

NCT00831116 is a study of Coronary Artery Disease and Myocardial Infarction that has completed, run by Infraredx. The registered enrollment target is 2,067 participants, above the 1,278-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00831116, a study of Coronary Artery Disease and Myocardial Infarction, has completed, sponsored by Infraredx.

COMPLETED
Registry status
2,067 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Coronary Artery Disease Myocardial Infarction Myocardial Ischemia Angina

Interventions

  • DEVICE Intravascular Near Infrared Spectroscopy

Study Locations (20)

California

  • University of California, Los Angeles Medical Center - Los Angeles
  • University of California Irvine Medical Center - Orange
  • San Francisco Veterans Affairs Medical Center - San Francisco

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Lahey Clinic - Burlington

Arizona

  • Mercy Gilbert Medical Center - Gilbert
  • Scottsdale Healthcare - Scottsdale

Florida

  • University of Florida, Gainesville - Gainesville
  • Pepin Heart Hospital - Tampa

Michigan

  • Crittenton Shelton Heart Center: - Rochester Hills
  • William Beaumont Hospital - Royal Oak

New York

  • Mount Sinai School of Medicine - New York
  • Columbia Universtiy Medical Center - New York

Georgia

  • Piedmont Hospital - Atlanta

Maryland

  • Washington Adventist Hospital - Takoma Park

Trial Details

FieldValue
Enrollment Target 2,067 participants
Start Date 2009-02
Est. Completion 2017-04

Sponsor

Infraredx

6 total trials

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What the Registry Record Tells You About NCT00831116

The ClinicalTrials.gov registry entry for NCT00831116 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,067 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,278-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (62% higher). The listed sponsor is Infraredx, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Intravascular Near Infrared Spectroscopy is the first listed.

NCT00831116 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT00831116 about?

NCT00831116 is a clinical study titled "An Observational Study of Cholesterol in Coronary Arteries". 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 ea...

What is the current status of trial NCT00831116?

This trial is currently completed. The enrollment target is 2,067 participants. The study started on 2009-02. Estimated completion is 2017-04.

What conditions does trial NCT00831116 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Angina.

What interventions are being tested in trial NCT00831116?

The interventions under investigation include: Intravascular Near Infrared Spectroscopy (DEVICE).

Who is sponsoring clinical trial NCT00831116?

This trial is sponsored by Infraredx, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00831116 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.