REASSURE-NIRS Registry

NCT04864171 | Recruiting FDA Device

• 1 other identifier: M30-084-4
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Lipid-Rich Atherosclerosis of Coronary Artery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MACE

  major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)

  at an average of 3 year

Secondary Outcomes (1)

• Coronary physiological characteristics at lipid-rich plaques

  Physiological measures are collected during the procedure: percutaneous coronary intervention

Other Outcomes (2)

• The occurrence of MACE in patients who achieved LDL-C <1.4 mmol/L

  at an average of 2 year

• gender difference in NIRS-derived measures

  NIRS-derived measures are collected during the procedure

Interventions

near-infrared spectroscopy DEVICE

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

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• poor quality of NIRS images

Sponsors & Collaborators

• National Cerebral and Cardiovascular Center, Japan: lead

Study Sites (2)

Miyazaki Medical Association Hospital

Miyazaki, 8802102, Japan

RECRUITING

National Cerebral & Cardiovascular Center

Suita, 5648565, Japan

RECRUITING

Related Publications (13)

• Kataoka Y, Puri R, Andrews J, Honda S, Nishihira K, Asaumi Y, Noguchi T, Yasuda S, Nicholls SJ. In vivo visualization of lipid coronary atheroma with intravascular near-infrared spectroscopy. Expert Rev Cardiovasc Ther. 2017 Oct;15(10):775-785. doi: 10.1080/14779072.2017.1367287. Epub 2017 Aug 28.

  PMID: 28846060 BACKGROUND

• Kitahara S, Kataoka Y, Miura H, Nishii T, Nishimura K, Murai K, Iwai T, Nakamura H, Hosoda H, Matama H, Doi T, Nakashima T, Honda S, Fujino M, Nakao K, Yoneda S, Nishihira K, Kanaya T, Otsuka F, Asaumi Y, Tsujita K, Noguchi T, Yasuda S. The feasibility and limitation of coronary computed tomographic angiography imaging to identify coronary lipid-rich atheroma in vivo: Findings from near-infrared spectroscopy analysis. Atherosclerosis. 2021 Apr;322:1-7. doi: 10.1016/j.atherosclerosis.2021.02.019. Epub 2021 Feb 24.

  PMID: 33706078 BACKGROUND

• Imamoto K, Kataoka Y, Hosoda H, Noguchi T. Suboptimal lipoprotein (a) control and residual plaque instability despite proprotein convertase subtilisin/kexin type 9 inhibitor use in heterozygous familial hypercholesterolaemia: insights from serial near-infrared spectroscopy imaging. Eur Heart J. 2021 Jun 7;42(22):2218-2219. doi: 10.1093/eurheartj/ehab218. No abstract available.

  PMID: 33822931 BACKGROUND

• Puri R, Madder RD, Madden SP, Sum ST, Wolski K, Muller JE, Andrews J, King KL, Kataoka Y, Uno K, Kapadia SR, Tuzcu EM, Nissen SE, Virmani R, Maehara A, Mintz GS, Nicholls SJ. Near-Infrared Spectroscopy Enhances Intravascular Ultrasound Assessment of Vulnerable Coronary Plaque: A Combined Pathological and In Vivo Study. Arterioscler Thromb Vasc Biol. 2015 Nov;35(11):2423-31. doi: 10.1161/ATVBAHA.115.306118. Epub 2015 Sep 3.

  PMID: 26338299 BACKGROUND

• Kitahara S, Kataoka Y, Sugane H, Otsuka F, Asaumi Y, Noguchi T, Yasuda S. In vivo imaging of vulnerable plaque with intravascular modalities: its advantages and limitations. Cardiovasc Diagn Ther. 2020 Oct;10(5):1461-1479. doi: 10.21037/cdt-20-238.

  PMID: 33224768 BACKGROUND

• Hosoda H, Kataoka Y, Otsuka F, Yasuda S. Severely calcified lipidic atheroma on intravascular ultrasound and near-infrared spectroscopy imaging: its association with slow-flow phenomenon during percutaneous coronary intervention. Eur Heart J Case Rep. 2019 Jun 1;3(2):ytz078. doi: 10.1093/ehjcr/ytz078. No abstract available.

  PMID: 31449658 BACKGROUND

• Nishihira K, Yamashita A, Kataoka Y, Shibata Y, Asada Y. Visualization of oxidized low-density lipoprotein at lipid-rich plaque in a ST-segment elevation myocardial infarction case with heterozygous familial hypercholesterolaemia: insights from near-infrared spectroscopy and histopathological analysis. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1316. doi: 10.1093/ehjci/jez156. No abstract available.

  PMID: 31180473 BACKGROUND

• Kaichi R, Kataoka Y, Yasuda S. Erupted coronary atheroma: insights from multi-modality imaging. Int J Cardiovasc Imaging. 2018 Oct;34(10):1669-1671. doi: 10.1007/s10554-018-1378-1. Epub 2018 May 24.

  PMID: 29799063 BACKGROUND

• Nishihira K, Otsuka F, Kataoka Y, Asaumi Y, Kaneta K, Nakano H, Ohta-Ogo K, Ishibashi-Ueda H, Noguchi T, Yasuda S. Embolization of Neoatherosclerosis After Percutaneous Coronary Intervention: Insights From Near-Infrared Spectroscopy Imaging and Histopathological Analysis. Circ Cardiovasc Interv. 2018 Feb;11(2):e006175. doi: 10.1161/CIRCINTERVENTIONS.117.006175. No abstract available.

  PMID: 29445002 BACKGROUND

• Nishihira K, Asaumi Y, Kataoka Y, Ishibashi-Ueda H, Yasuda S. In vivo comparison of lipid-rich plaque on near-infrared spectroscopy with histopathological analysis of coronary atherectomy specimens. Eur Heart J Cardiovasc Imaging. 2018 Jan 1;19(1):116. doi: 10.1093/ehjci/jex247. No abstract available.

  PMID: 29040461 BACKGROUND

• Gilard M, Wijns W. High-Intensity Lipid-Lowering Therapies: An Opportunity for Improving Cardiovascular Outcomes in Postmenopausal Women? Circ Cardiovasc Imaging. 2023 May;16(5):e015544. doi: 10.1161/CIRCIMAGING.123.015544. Epub 2023 May 10. No abstract available.

  PMID: 37161823 DERIVED

• Kataoka Y, Nicholls SJ, Puri R, Kitahara S, Kiyoshige E, Nishimura K, Murai K, Iwai T, Sawada K, Matama H, Honda S, Takagi K, Fujino M, Yoneda S, Otsuka F, Nishihira K, Takamisawa I, Asaumi Y, Noguchi T. Sex Differences in the Density of Lipidic Plaque Materials: Insights From the REASSURE-NIRS MultiCenter Registry. Circ Cardiovasc Imaging. 2023 May;16(5):e015107. doi: 10.1161/CIRCIMAGING.122.015107. Epub 2023 May 10.

  PMID: 37161775 DERIVED

• 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. 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. Atherosclerosis. 2022 May;349:183-189. doi: 10.1016/j.atherosclerosis.2022.03.033. Epub 2022 Apr 10.

  PMID: 35450750 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Yu Kataoka, MD

  National Cerebral & Cardiovascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Kataoka, MD

CONTACT

+81661701070; yu.kataoka@ncvc.go.jp

Kota Murai, MD

CONTACT

+81661701070; murai.kota11@ncvc.go.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief consultant

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: October 9, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

JP (2)