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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| near-infrared spectroscopy | Device | Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization) | at an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Physiological measures are collected during the procedure: percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of MACE in patients who achieved LDL-C <1.4 mmol/L | The efficacy of LDL-C <1.4 mmol/L on MACE | at an average of 2 year |
| gender difference in NIRS-derived measures | sex-related difference in maxLCBI |
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
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Study population should be patients with coronary artery disease who requires coronary angiography and/or percutaneous coronary intervention with NIRS imaging
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Kataoka, MD | Contact | +81661701070 | 60189 | yu.kataoka@ncvc.go.jp |
| Kota Murai, MD | Contact | +81661701070 | 60162 | murai.kota11@ncvc.go.jp |
| Name | Affiliation | Role |
|---|---|---|
| Yu Kataoka, MD | National Cerebral & Cardiovascular Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miyazaki Medical Association Hospital | Recruiting | Miyazaki | 8802102 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28846060 | Background | 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. | |
| 26338299 | Background |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| NIRS-derived measures are collected during the procedure |
| National Cerebral & Cardiovascular Center | Recruiting | Suita | 5648565 | Japan |
|
| 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. |
| 33224768 | 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. |
| 33706078 | Result | 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. |
| 33822931 | Result | 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. |
| 31449658 | Result | 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. |
| 31180473 | Result | 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. |
| 29799063 | Result | 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. |
| 29445002 | Result | 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. |
| 29040461 | Result | 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. |
| 37161823 | Derived | 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. |
| 37161775 | 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. |
| 35450750 | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |