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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02265146

Acronym

ORACLE-NIRS

Enrollment

Registered

2014-10-15

Start date

2014-09-30

Completion date

2030-12-31

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Atherosclerosis

Keywords

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results