REASSURE-NIRS Registry

Last updated: August 12, 2025
Sponsor: National Cerebral and Cardiovascular Center, Japan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Cardiac Disease

Coronary Artery Disease

Treatment

near-infrared spectroscopy

Clinical Study ID

NCT04864171
M30-084-4
  • Ages 20-95
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

poor quality of NIRS images

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: near-infrared spectroscopy
Phase:
Study Start date:
October 09, 2018
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • Miyazaki Medical Association Hospital

    Miyazaki, 8802102
    Japan

    Active - Recruiting

  • National Cerebral & Cardiovascular Center

    Suita, 5648565
    Japan

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.