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NCT Number: NCT04864171

REASSURE-NIRS Registry

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.

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Key information

Conditions

Lipid-Rich Atherosclerosis of Coronary Artery Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Miyazaki Medical Association Hospital, Miyazaki, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-infrared spectroscopy

Device

Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. gender difference in NIRS-derived measures

    Time frame: NIRS-derived measures are collected during the procedure

    sex-related difference in maxLCBI

Study contacts

Contact information is provided by the study sponsor or research team.

Kota Murai, MD

CONTACT

[email protected]

+81661701070 ext. 60162

Yu Kataoka, MD

CONTACT

[email protected]

+81661701070 ext. 60189

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Registry information

Official study title

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

Acronym: REASSURENIRS

Important dates

Study start
2018
Primary completion
2028
Study completion
2030
First posted
Apr 28, 2021
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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