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

NCT02265146 | Withdrawn

• 1 other identifier: STU 112013-073
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 5

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).

Conditions

Coronary Atherosclerosis

Keywords

Lipid Core Plaques (LCPs); Vulnerable Plaque; Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of major adverse cardiac events

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (5)

North Florida/(South Georgia) VA Health Care System

Gainesville, Florida, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, United States

Location

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Location

VA North Texas Health Care System

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Emmanouil S Brilakis, MD, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 15, 2014
• Study Start: September 1, 2014
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (5)