无血运重建术的稳定性缺血性心脏病患者的心脏康复——单组先导研究的基本原理和设计

Tomotsugu Seki, Makoto Murata, Kensuke Takabayashi, Takashi Yanagisawa, Masayuki Ogihara, Ritsuko Kurimoto, Keisuke Kida, Koichi Tamita, Xiaoyang Song, Neiko Ozasa, Ryoji Taniguchi, Miho Nishitani-Yokoyama, Shinji Koba, Ryosuke Murai, Yutaka Furukawa, Maki Hamasaki, Hirokazu Kondo, Hironori Hayashi, Asako Ootakara-Katsume, Kento Tateishi, Satoaki Matoba, Hitoshi Adachi, Hirokazu Shiraishi
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引用次数: 0

摘要

背景:临床实践指南强烈推荐稳定型缺血性心脏病(SIHD)患者采用最佳药物治疗(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在没有血运重建术的SIHD患者中的疗效和安全性尚不清楚。方法和结果:稳定性心绞痛康复前瞻性登记(Pre-START)研究是一项多中心、前瞻性、单组、开放标签的先导研究,旨在评估CR对日本SIHD无血运重建术患者健康相关生活质量(HRQL)、运动能力和临床结果的疗效和安全性。在本研究中,所有患者将接受基于指南的OMT,并鼓励在入组后5个月内进行36次门诊CR。主要终点是西雅图心绞痛问卷-7总结评分在基线和6个月访问之间的变化;改善≥5分将被定义为临床重要改变。次要终点包括基线至6个月随访期间其他HRQL评分和运动能力的变化,以及入组至6个月随访期间的临床结果。结论:Pre-START研究将为阐明CR在SIHD患者中的有效性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。该研究已于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)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization - Rationale and Design of a Single-Arm Pilot Study.

Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization - Rationale and Design of a Single-Arm Pilot Study.

Background: 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. Methods and Results: 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. Conclusions: 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.

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