REASSURE-NIRS registry of lipid-rich plaque in coronary arteries
Official title: REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS
Run by National Cerebral and Cardiovascular Center, Japan · NCT04864171 · Data updated 2026-11-12
This registry will use near-infrared spectroscopy during angiography to see how lipid-rich plaque in people with coronary artery disease relates to risk factors, medications, procedures, and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 95 Years |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | National Cerebral and Cardiovascular Center, Japan Academic / other |
| Locations | 2 sites (Miyazaki and 1 other locations) |
| Status | Recruiting |
| Started | October 9, 2018 |
| Main results expected | December 31, 2028 |
| Study ends | March 31, 2030 |
| Registry record updated | August 15, 2025 |
| Trial ID | NCT04864171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults in Japan with coronary artery disease who are undergoing coronary angiography or percutaneous coronary intervention and receive NIRS imaging of their coronary lesions.
✕Probably not a fit
Patients without coronary artery disease, those not undergoing NIRS imaging, or cases with poor-quality NIRS images are unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
REASSURE-NIRS is a multicenter prospective registry in Japan enrolling about 2,000 patients with coronary artery disease who undergo near-infrared spectroscopy (NIRS) imaging during coronary angiography or PCI. NIRS is an invasive intravascular imaging method that quantitatively visualizes lipid-rich atheroma in vivo. The primary measure is the maximum 4-mm lipid core burden index (LCBI) at coronary lesions, with secondary outcomes including whole-lesion LCBI, plaque volume, attenuation, and echo-lucent areas. The registry aims to link NIRS-derived plaque characteristics with clinical risk factors, medication use, prognosis, and response to PCI.
Why it matters
Potential benefit: If successful, the registry could help doctors identify high-risk lipid-rich plaques and better target treatments to reduce future cardiovascular events.
How similar studies have gone: Previous NIRS studies have shown that lipid-rich plaques are associated with higher cardiovascular event rates, but large prospective registries linking NIRS findings to treatments and outcomes remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Miyazaki Medical Association Hospital
Miyazaki, Japan Recruiting -
National Cerebral & Cardiovascular Center
Suita, Japan Recruiting
Study contacts
- Principal investigator: Yu Kataoka, MD — National Cerebral & Cardiovascular Center
- Study coordinator: Yu Kataoka, MD
- Email: yu.kataoka@ncvc.go.jp
- Phone: +81661701070
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.