REASSURE-NIRS Registry

Lipid-Rich Atherosclerosis of Coronary Artery Clinical Trial

— REASSURENIRS  

Official title:

REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864171
• Other study ID #: M30-084-4
• Status: Recruiting
• Start date: October 9, 2018
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2022
• Source: National Cerebral and Cardiovascular Center
• Contact: Yu Kataoka, MD
• Phone: +81661701070
• Email: yu.kataoka[@]ncvc.go.jp
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Lipid-Rich Atherosclerosis of Coronary Artery
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	National Cerebral & Cardiovascular Center	Suita

Sponsors (1)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center

Country where clinical trial is conducted

Japan, 

References & Publications (10)

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. 201 — View 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-inf — View 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. — View 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. — View 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 an — View 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. — View 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. do — View 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 Histopatho — View 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-infra — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	gender difference in NIRS-derived measures	sex-related difference in maxLCBI	NIRS-derived measures are collected during the procedure
Primary	MACE	major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)	at an average of 2 year
Secondary	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