Clinical trial NCT04864171: REASSURE-NIRS Registry
Official title: REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lipid-Rich Atherosclerosis of Coronary Artery
Keywords: near-infrared spectroscopy
lipid-rich plaque
coronary artery disease
intravascular imaging
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE
timeFrame: at an average of 2 year
Secondary outcomes:
measure: Coronary physiological characteristics at lipid-rich plaques
timeFrame: Physiological measures are collected during the procedure: percutaneous coronary intervention
Other outcomes:
measure: The occurrence of MACE in patients who achieved LDL-C <1.4 mmol/L
timeFrame: at an average of 2 year
measure: gender difference in NIRS-derived measures
timeFrame: NIRS-derived measures are collected during the procedure
Locations:
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Suita
country: Japan
facility: National Cerebral & Cardiovascular Center
Study officials:
affiliation: National Cerebral & Cardiovascular Center
name: Yu Kataoka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.