Lipid-Rich Atherosclerosis of Coronary ArteryREASSURENIRSNCT04864171
REASSURE-NIRS Registry
An observational study of Lipid-Rich Atherosclerosis of Coronary Artery, run by National Cerebral and Cardiovascular Center, Japan at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Lipid-Rich Atherosclerosis of Coronary Artery
- What is being tested?
- near-infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 2 sitesJapan
- Study dates
- 9 Oct 2018to 31 Mar 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population should be patients with coronary artery disease who requires coronary angiography and/or percutaneous coronary intervention with NIRS imaging
Who may be able to join
- patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS
Who cannot join
- poor quality of NIRS images
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan2 sites, 2 recruiting
- Recruiting
Miyazaki Medical Association Hospital
Miyazaki, 8802102
Kensaku Nishihira, MD, +81985779101 ext. 60111, nishihira@med.miyazaki-u.ac.jp
Kensaku Nishihira, MD
- Recruiting
National Cerebral & Cardiovascular Center
Suita, 5648565
Yu Kataoka, MD, +81661701070 ext. 60189, yu.kataoka@ncvc.go.jp
Yu Kataoka, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- near-infrared spectroscopy
- Keywords
- near-infrared spectroscopy, lipid-rich plaque, coronary artery disease, intravascular imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near-infrared spectroscopyDevice
Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)
Measured: at an average of 3 year
Secondary outcomes (1)
Coronary physiological characteristics at lipid-rich plaques
Identify and quantify coronary physiological findings (=fractional flow reserve and delta fractional flow reserve) for cardiovascular risk stratification of persons with lipid-rich plaques.
Measured: Physiological measures are collected during the procedure: percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start9 Oct 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lipid-Rich Atherosclerosis of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Cerebral and Cardiovascular Center, Japan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Kataoka, National Cerebral and Cardiovascular Center, Japan
- Investigators
- Yu Kataoka, MD, Principal investigator, National Cerebral & Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864171
- Sponsor's protocol ID
- M30-084-4
- Acronym
- REASSURENIRS
- Status last verified
- Aug 2025
- First submitted
- 24 Apr 2021
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 28846060Puri 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.
PubMed 26338299Kitahara 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.
PubMed 33224768Kitahara 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.
PubMed 33706078Imamoto 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.
PubMed 33822931Hosoda 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.
PubMed 31449658Nishihira 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.
PubMed 31180473Kaichi 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.
PubMed 29799063Nishihira 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.
PubMed 29445002Nishihira 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.
PubMed 29040461Mitsui K, Kataoka Y, Nicholls SJ, Kiyoshige E, Nishimura K, Puri R, Murai K, Sawada K, Matama H, Iwai T, Honda S, Fujino M, Nakao K, Takagi K, Yoneda S, Otsuka F, Nishihira K, Takamisawa I, Asaumi Y, Tsujita K, Noguchi T. Lipidic contents within calcified plaques: Characteristics and response to LDL-C<55 mg/dL on multi-modality imaging. Atherosclerosis. 2026 Feb;413:120500. doi: 10.1016/j.atherosclerosis.2025.120500. Epub 2026 Jan 12.
PubMed 41651577Gilard 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.
PubMed 37161823Kataoka 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.
PubMed 37161775Nakamura 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.
PubMed 35450750
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS
- ClinicalTrials.gov ID
- NCT04864171
- Acronym / sponsor ID
- REASSURENIRS / M30-084-4
- Keywords
- near-infrared spectroscopy, lipid-rich plaque, coronary artery disease, intravascular imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Cerebral and Cardiovascular Center, JapanUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population should be patients with coronary artery disease who requires coronary angiography and/or percutaneous coronary intervention with NIRS imaging
Key inclusion criteria (1 listed)
- patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS
Key exclusion criteria (1 listed)
- poor quality of NIRS images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near-infrared spectroscopyNear-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery. | Device | – |
Primary outcome
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)
1 secondary outcome
Coronary physiological characteristics at lipid-rich plaques
Time frame: Physiological measures are collected during the procedure: percutaneous coronary intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 28846060Kataoka 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.
- Background: PubMed 26338299Puri 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.
- Background: PubMed 33224768Kitahara 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.
- Results publication: PubMed 33706078Kitahara 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.
- Results publication: PubMed 33822931Imamoto 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.
- Results publication: PubMed 31449658Hosoda 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.
- Results publication: PubMed 31180473Nishihira 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.
- Results publication: PubMed 29799063Kaichi 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.
- Results publication: PubMed 29445002Nishihira 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.
- Results publication: PubMed 29040461Nishihira 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.
- Derived from this study: PubMed 41651577Mitsui K, Kataoka Y, Nicholls SJ, Kiyoshige E, Nishimura K, Puri R, Murai K, Sawada K, Matama H, Iwai T, Honda S, Fujino M, Nakao K, Takagi K, Yoneda S, Otsuka F, Nishihira K, Takamisawa I, Asaumi Y, Tsujita K, Noguchi T. Lipidic contents within calcified plaques: Characteristics and response to LDL-C<55 mg/dL on multi-modality imaging. Atherosclerosis. 2026 Feb;413:120500. doi: 10.1016/j.atherosclerosis.2025.120500. Epub 2026 Jan 12.
- Derived from this study: PubMed 37161823Gilard 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yu Kataoka, MD principal investigator
National Cerebral & Cardiovascular Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid-Rich Atherosclerosis of Coronary Artery, run by National Cerebral and Cardiovascular Center, Japan at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Kataoka, MD (+81661701070 ext. 60189, yu.kataoka@ncvc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: at an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864171, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.