REASSURE-NIRS Registry

Recruiting

• Conditions: Lipid-Rich Atherosclerosis of Coronary Artery

• Registration Number: NCT04864171
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

Brief Summary

RESSURE-NIRS registry is designed to investigate clinical and pathophysiological characteristics of NIRS-derived lipid-rich plaque in patients with coronary artery disease. This is an on-going multi-center prospective registry in Japan.

Detailed Description

NIRS imaging is an invasive intravascular imaging modality to quantitatively visualize lipid-rich atheroma in vivo. While NIRS-derived lipid-rich plaque has been shown to associate with cardiovascular events, there is limited clinical data about the association of this high-risk plaque with risk factors, medication use, prognosis and response of PCI. RESSURE-NIRS registry is an on-going multi-center prospective registry in Japan, which enroll subjects with coronary artery disease who received NIRS imaging to evaluate coronary atherosclerosis. The primary outcome is maximum 4-mm lipid core burden index at coronary lesions measured by NIRS imaging. Secondary major outcomes include entire lipid core burden index, plaque volume, plaque attenuation and echo-lucent area. The anticipated number of study subjects is 2000 cases.

Study Timeline

• Study Start: 2018-10-09
• Study First Submitted: 2021-04-24
• Study First Submitted QC: 2021-04-24
• Study First Posted: 2021-04-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS

Exclusion Criteria

poor quality of NIRS images

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	at an average of 2 year	major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)

Secondary Outcome Measures

Name	Time	Method
Coronary physiological characteristics at lipid-rich plaques	Physiological measures are collected during the procedure: percutaneous coronary intervention	Identify and quantify coronary physiological findings (=fractional flow reserve and delta fractional flow reserve) for cardiovascular risk stratification of persons with lipid-rich plaques.

Trial Locations

Locations (2)

National Cerebral & Cardiovascular Center; 🇯🇵 Suita, Japan

Miyazaki Medical Association Hospital; 🇯🇵 Miyazaki, Japan