REASSURE-NIRS Registry

Conditions

Lipid-Rich Atherosclerosis of Coronary Artery

Keywords

near-infrared spectroscopy, lipid-rich plaque, coronary artery disease, intravascular imaging

Brief 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.

Kataoka Y, Nicholls SJ, Kiyoshige E, Nishimura K, Puri R, Kitahara S, Murai K, Mitsui K, Tomishima Y, Sawada K, Matama H, Iwai T, Honda S, Nakao K, Fujino M, Takagi K, Yoneda S, Otsuka F, Nishihira K, Takamisawa I, Asaumi Y, Noguchi T.

2026-02-25

10.1093/ehjci/jeag057

Characterization of lipidic plaque features in association with LDL-C<70 mg/dL and lipoprotein(a) <50 mg/dL.

Shishikura D, Kataoka Y, Nicholls SJ, Ray KK, Puri R, Kusumoto H, Yamauchi Y, Sakane K, Fujisaka T, Morita H, Murai K, Iwai T, Sawada K, Matama H, Honda S, Fujino M, Yoneda S, Takagi K, Nakao K, Otsuka F, Nishihira K, Takamisawa I, Asaumi Y, Noguchi T, Harada-Shiba M, Hoshiga M.

2025-01-033 citations

10.1016/j.jacl.2024.12.019

Characterization of lipidic coronary atheroma under control of low-density lipoprotein &lt;1.8 mmol/l and lipoprotein (a) &lt;50 mg/dl in patients with coronary artery disease

Daisuke Shishikura, Yu Kataoka, Hidenori Kusumoto, Yohei Yamauchi, Kazushi Sakane et al. (15 authors)

European Heart Journal2023-11-011 citations

10.1093/eurheartj/ehad655.2503

Characterization of plaque phenotypes exhibiting an elevated pericoronary adipose tissue attenuation: insights from the REASSURE-NIRS registry

Satoshi Kitahara, Yu Kataoka, Hiroyuki Miura, Tatsuya Nishii, Kunihiro Nishimura et al. (19 authors)

The International Journal of Cardiovascular Imaging2023-06-293 citations

10.1007/s10554-023-02907-w

Calcified plaque harboring lipidic materials associates with no-reflow phenomenon after PCI in stable CAD.

Hosoda H, Kataoka Y, Nicholls SJ, Puri R, Murai K, Kitahara S, Mitsui K, Sugane H, Sawada K, Iwai T, Matama H, Honda S, Takagi K, Fujino M, Yoneda S, Otsuka F, Takamisawa I, Nishihira K, Asaumi Y, Kawai K, Noguchi T.

2023-06-28

10.1007/s10554-023-02905-y

Sex Differences in the Density of Lipidic Plaque Materials: Insights From the REASSURE-NIRS MultiCenter Registry

Yu Kataoka, Stephen J. Nicholls, Rishi Puri, Satoshi Kitahara, Eri Kiyoshige et al. (19 authors)

Circulation Cardiovascular Imaging2023-05-017 citations

10.1161/circimaging.122.015107

Abstract 11785: Phenotype Features of Coronary Atheroma in Association With an Elevated Activity of Pericoronary Adipose Tissue (Insights From Computed Coronary Angiography and Near-Infrared Spectroscopy Analysis)

Satoshi Kitahara, Yu Kataoka, Hiroyuki Miura, Tatsuya Nishii, Kota Murai et al. (17 authors)

Circulation2022-11-08

10.1161/circ.146.suppl_1.11785

Characterization of lipidic plaque materials at calcified atheroma: its association with calcification thickness evaluated by optical coherence tomography and near-infrared spectroscopy imaging

Kentaro Mitsui, Yuko Kataoka, Kota Murai, Satoshi Kitahara, Takamasa Iwai et al. (15 authors)

European Heart Journal2022-10-01

10.1093/eurheartj/ehac544.1207

Elevated Lipoprotein(a) as a potential residual risk factor associated with lipid-rich coronary atheroma in patients with type 2 diabetes and coronary artery disease on statin treatment: Insights from the REASSURE-NIRS registry.

Nakamura H, Kataoka Y, Nicholls SJ, Puri R, Kitahara S, Murai K, Sawada K, Matama H, Iwai T, Honda S, Fujino M, Takagi K, Yoneda S, Otsuka F, Nishihira K, Asaumi Y, Tsujita K, Noguchi T.

2022-04-1014 citations

10.1016/j.atherosclerosis.2022.03.033

Interventions

DEVICEnear-infrared spectroscopy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 95 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Coronary physiological characteristics at lipid-rich plaques	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

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

Countries

Japan

Contacts

Primary ContactYu Kataoka, MD

yu.kataoka@ncvc.go.jp+81661701070

Backup ContactKota Murai, MD

murai.kota11@ncvc.go.jp+81661701070

Outcome results

None listed