REASSURE-NIRS Registry (REASSURENIRS)

August 12, 2025 updated by: Yu Kataoka, National Cerebral and Cardiovascular Center, Japan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Miyazaki, Japan, 8802102
        • Recruiting
        • Miyazaki Medical Association Hospital
        • Contact:
        • Principal Investigator:
          • Kensaku Nishihira, MD
      • Suita, Japan, 5648565
        • Recruiting
        • National Cerebral & Cardiovascular Center
        • Contact:
        • Principal Investigator:
          • Yu Kataoka, MD
        • Sub-Investigator:
          • Kota Murai, MD
        • Sub-Investigator:
          • Satoshi Kitahara, MD
        • Sub-Investigator:
          • Takamasa Iwai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population should be patients with coronary artery disease who requires coronary angiography and/or percutaneous coronary intervention with NIRS imaging

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: at an average of 3 year
major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)
at an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary physiological characteristics at lipid-rich plaques
Time Frame: 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.
Physiological measures are collected during the procedure: percutaneous coronary intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of MACE in patients who achieved LDL-C <1.4 mmol/L
Time Frame: at an average of 2 year
The efficacy of LDL-C <1.4 mmol/L on MACE
at an average of 2 year
gender difference in NIRS-derived measures
Time Frame: NIRS-derived measures are collected during the procedure
sex-related difference in maxLCBI
NIRS-derived measures are collected during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cerebral and Cardiovascular Center, Japan

Investigators

  • Principal Investigator: Yu Kataoka, MD, National Cerebral & Cardiovascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

April 24, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M30-084-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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