Details

Autor(en) / Beteiligte

• 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
• Investigators, for the START

Titel

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

Ist Teil von

• Circulation Reports, 2023/03/10, Vol.5(3), pp.90-94

Ort / Verlag

Japan: The Japanese Circulation Society

Erscheinungsjahr

2023

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• 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.