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.
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.
著者
Tomotsugu Seki Masato Takeuchi Shin Kawasoe Kazufumi Takeuchi Ryusuke Miki Kenji Ueshima Koji Kawakami
出版者
Society for Clinical Epidemiology
雑誌
Annals of Clinical Epidemiology (ISSN:24344338)
巻号頁・発行日
vol.3, no.1, pp.10-26, 2021 (Released:2021-01-07)
参考文献数
32

BACKGROUNDSurvival benefit of outpatient cardiac rehabilitation (CR) after acute myocardial infarction (AMI) has recently been contested under the current real-world clinical practice. We investigated whether outpatient CR was associated with lower mortality and morbidity risks among Japanese AMI patients.METHODSWe analyzed patients who were admitted for AMI and received both percutaneous coronary intervention and inpatient CR from January 2011 to December 2014, using a nationwide administrative database in Japan (final date of follow-up: July 31, 2016). We compared patients who received outpatient CR and who did not, and the primary outcome was a composite of all-cause death and recurrence of AMI after the landmark time-point of day 180 after discharge. We applied Cox proportional hazards model to estimate outcomes, and propensity-score matching was applied to adjust for baseline imbalances.RESULTSA total of 5,654 patients (mean [SD] age, 66.8 [12.4] years; 21.2% female; median follow-up period [IQR] 1.44 [0.87, 2.27] years), 730 (12.9%) participated in outpatient CR at least once within 180 days of discharge. Of 1,458 propensity-score matched patients, outpatient CR participation was associated with lower but statistically non-significant risks among the primary outcome (1.38 vs. 2.12 per 100 patient-years; HR = 0.71; 95%CI, 0.32 to 1.61).CONCLUSIONSAmong Japanese patients who admitted for AMI and received both percutaneous coronary intervention and inpatient CR, outpatient CR was underutilized, and associated with a statistically non-significant mortality and morbidity benefits. Further study is necessary to reaffirm the real-world effectiveness of outpatient CR under the current real-world clinical practice.