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

Withdrawn

• Conditions: Coronary Atherosclerosis

• Registration Number: NCT02265146
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiac events	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.

Trial Locations

Locations (5)

Minneapolis VA Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States

North Florida/(South Georgia) VA Health Care System; 🇺🇸 Gainesville, Florida, United States

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States