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

Coronary Atherosclerosis Clinical Trial

— ORACLE-NIRS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02265146
• Other study ID #: STU 112013-073
• Status: Withdrawn
• Start date: September 2014
• Est. completion date: December 2030

Study information

• Verified date: October 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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