跳至主要内容
临床试验/NCT04864171
NCT04864171招募中不适用

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

National Cerebral and Cardiovascular Center, Japan2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
2
主要终点
MACE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS

排除标准

  • poor quality of NIRS images

结局指标

主要结局

MACE

时间窗: at an average of 3 year

major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)

次要结局

  • Coronary physiological characteristics at lipid-rich plaques(Physiological measures are collected during the procedure: percutaneous coronary intervention)

研究者

发起方
National Cerebral and Cardiovascular Center, Japan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Kataoka

Chief consultant

National Cerebral and Cardiovascular Center, Japan

研究点 (2)

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