ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study (ORACLE-NIRS)

October 18, 2023 updated by: University of Texas Southwestern Medical Center

Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study

This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States
        • North Florida/(South Georgia) VA Health Care System
    • Georgia
      • Atlanta, Georgia, United States
        • Atlanta VA Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • Jesse Brown VA Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Minneapolis VA Medical Center
    • Texas
      • Dallas, Texas, United States
        • VA North Texas Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing clinically-indicated Near Infrared Spectroscopy (NIRS) among various participating centers.

Description

Inclusion Criteria:

1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiac events
Time Frame: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging

The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following:

  • cardiac death
  • cardiac arrest
  • acute coronary syndrome
  • stent thrombosis, repeat coronary angiography
  • coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery).
  • rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy).

Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.
1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Emmanouil S Brilakis, MD, PhD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimated)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU 112013-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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