NCT04864171

REASSURE-NIRS Registry

REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: National Cerebral and Cardiovascular Center, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lipid-Rich Atherosclerosis of Coronary Artery

Interventions

Type	Name	Description
DEVICE	near-infrared spectroscopy	Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.

Timeline

• Start date: 2018-10-09
• Primary completion: 2028-12-31
• Completion: 2030-03-31
• First posted: 2021-04-28
• Last updated: 2025-08-15

Locations

2 sites across 1 country: Japan

Regulatory

• FDA-regulated device study