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3 0 0 0 OA Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization ― Rationale and Design of a Single-Arm Pilot Study ―

著者
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 for the START Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
vol.5, no.3, pp.90-94, 2023-03-10 (Released:2023-03-10)
参考文献数
18
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.

1 0 0 0 OA Cardiac Rehabilitation for Patients With Stable Ischemic Heart Disease Without Revascularization ― Rationale and Design of a Single-Arm Pilot Study ―

著者
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 for the START Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Reports (ISSN:24340790)
巻号頁・発行日
pp.CR-22-0131, (Released:2023-02-25)
参考文献数
18
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.