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COMPLETED

An Observational Study of Cholesterol in Coronary Arteries

NCT00831116 · View on ClinicalTrials.gov ↗

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.

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00831116

The ClinicalTrials.gov registry entry for NCT00831116 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,067 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Infraredx, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00831116 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Massachusetts, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00831116?

The interventions under investigation include: Intravascular Near Infrared Spectroscopy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00831116?

This trial is sponsored by Infraredx, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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