REASSURE-NIRS Registry

NCT ID: NCT04864171

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-09

Study Completion Date

2030-03-31

Brief Summary

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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

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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.

Conditions

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Lipid-Rich Atherosclerosis of Coronary Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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near-infrared spectroscopy

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role lead

Responsible Party

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Yu Kataoka

Chief consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu Kataoka, MD

Role: PRINCIPAL_INVESTIGATOR

National Cerebral & Cardiovascular Center

Locations

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Miyazaki Medical Association Hospital

Miyazaki, , Japan

Site Status RECRUITING

National Cerebral & Cardiovascular Center

Suita, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Yu Kataoka, MD

Role: CONTACT

+81661701070 ext. 60189

Kota Murai, MD

Role: CONTACT

+81661701070 ext. 60162

Facility Contacts

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Kensaku Nishihira, MD

Role: primary

+81985779101 ext. 60111

Yu Kataoka, MD

Role: primary

+81661701070 ext. 60189

References

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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.

Reference Type BACKGROUND
PMID: 28846060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33706078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33822931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26338299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33224768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31449658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31180473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29799063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29445002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29040461 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37161823 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37161775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35450750 (View on PubMed)

Other Identifiers

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M30-084-4

Identifier Type: -

Identifier Source: org_study_id

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