REASSURE-NIRS Registry
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: near-infrared spectroscopy.
- Кому может быть актуально
- Состояния в реестре: Lipid-Rich Atherosclerosis of Coronary Artery. Базовые параметры: 20 лет — 95 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Япония
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство near-infrared spectroscopy
Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.
Первичные конечные точки
- MACE [Срок оценки: at an average of 3 year]
Вторичные конечные точки (1)
- Coronary physiological characteristics at lipid-rich plaques [Срок оценки: Physiological measures are collected during the procedure: percutaneous coronary intervention]
Критерии участия
Критерии включения
patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS
Критерии исключения
poor quality of NIRS images
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Япония · 2 центра
- Miyazaki Medical Association Hospital — Miyazaki
- National Cerebral & Cardiovascular Center — Suita
Публикации
- 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. PMID 28846060
- 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.11 PMID 26338299
- 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. PMID 33224768
- 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 s PMID 33706078
- 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. PMID 33822931
- 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. PMID 31449658
- 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 a PMID 31180473
- 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. PMID 29799063
Идентификаторы
NCT: NCT04864171 · M30-084-4