Seki Tomotsugu, Murata Makoto, Takabayashi Kensuke, Yanagisawa Takashi, Ogihara Masayuki, Kurimoto Ritsuko, Kida Keisuke, Tamita Koichi, Song Xiaoyang, Ozasa Neiko, Taniguchi Ryoji, Nishitani-Yokoyama Miho, Koba Shinji, Murai Ryosuke, Furukawa Yutaka, Hamasaki Maki, Kondo Hirokazu, Hayashi Hironori, Ootakara-Katsume Asako, Tateishi Kento, Matoba Satoaki, Adachi Hitoshi, Shiraishi Hirokazu
Department of Cardiovascular Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine Kyoto Japan.
Department of Cardiology, Gunma Prefectural Cardiovascular Center Maebashi Japan.
Circ Rep. 2023 Feb 25;5(3):90-94. doi: 10.1253/circrep.CR-22-0131. eCollection 2023 Mar 10.
Clinical practice guidelines strongly recommend optimal medical therapy (OMT), including lifestyle modification, pharmacotherapy, and exercise-based cardiac rehabilitation (CR), in patients with stable ischemic heart disease (SIHD). However, the efficacy and safety of CR in patients with SIHD without revascularization remain unclear. The Prospective Registry of STable Angina RehabiliTation (Pre-START) study is a multicenter, prospective, single-arm, open-label pilot study to evaluate the efficacy and safety of CR on health-related quality of life (HRQL), exercise capacity, and clinical outcomes in Japanese patients with SIHD without revascularization. In this study, all patients will undergo guideline-based OMT and are encouraged to have 36 outpatient CR sessions within 5 months after enrollment. The primary endpoint is the change in the Seattle Angina Questionnaire-7 summary score between baseline and the 6-month visit; an improvement of ≥5 points will be defined as a clinically important change. Secondary endpoints include changes in other HRQL scores and exercise capacity between baseline and the 6-month visit, as well as clinical outcomes between enrollment and the 6-month visit. The Pre-START study will provide valuable evidence to elucidate the efficacy and safety of CR in patients with SIHD and indispensable information for a subsequent randomized controlled trial. The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (ID: UMIN000045415) on April 1, 2022.
临床实践指南强烈推荐对稳定型缺血性心脏病（SIHD）患者进行优化药物治疗（OMT），包括生活方式改变、药物治疗和基于运动的心脏康复（CR）。然而，CR在未进行血运重建的SIHD患者中的疗效和安全性仍不明确。稳定型心绞痛康复前瞻性注册研究（Pre-START）是一项多中心、前瞻性、单臂、开放标签的试点研究，旨在评估CR对未进行血运重建的日本SIHD患者的健康相关生活质量（HRQL）、运动能力和临床结局的疗效和安全性。在本研究中，所有患者将接受基于指南的OMT，并被鼓励在入组后5个月内进行36次门诊CR治疗。主要终点是西雅图心绞痛问卷-7总结评分在基线和6个月随访之间的变化；改善≥5分将被定义为具有临床意义的变化。次要终点包括基线和6个月随访之间其他HRQL评分和运动能力的变化，以及入组和6个月随访之间的临床结局。Pre-START研究将为阐明CR在SIHD患者中的疗效和安全性提供有价值的证据，并为后续的随机对照试验提供不可或缺的信息。该研究于2022年4月1日在大学医院医学信息网络（UMIN）临床试验注册中心注册（ID：UMIN000045415）。
