Wang Tao, Xu Yueqiao, Wang Ning, Qi Meng, Cheng Weitao, Qu Xin
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Front Neurol. 2020 Apr 28;11:286. doi: 10.3389/fneur.2020.00286. eCollection 2020.
Takotsubo syndrome (TTS) is an acute heart failure syndrome which is preceded by a variety of emotional or physical triggers, with central nervous system conditions being an important trigger. Remote ischemic conditioning (RIC) is a promising interventional treatment based on the probability that both TTS and acute coronary syndrome may respond similarly to interventions. The heart protection effect of RIC has been repeatedly confirmed in animal models and observational clinical trials; however, it has never been studied in patients with TTS after acute stroke in randomized clinical trials with a higher level of evidence. The present study will be a proof-of-concept study to determine whether RIC can reduce cardiac injury and eventually improve the heart function and clinical outcomes of TTS patients after acute stroke. A single-center, outcome-assessor-blinded, randomized controlled trial (RCT) will be conducted to evaluate the effect of RIC in TTS patients after acute stroke. Major eligibility criteria include TTS patients diagnosed with acute stroke, which can be confirmed on computed tomography or magnetic resonance imaging; patients aged 18-75 years; patients admitted to a hospital within 48 h after the onset of acute stroke; and patients diagnosed with Takotsubo cardiomyopathy with an InterTAK diagnostic score ≥50. A total of 60 eligible patients will be randomly allocated into either the RIC or the control group. The primary endpoint is a composite of death from any cause and major adverse cardiac and cerebrovascular events during the in-hospital period and at the 1- and 6-month follow-up. This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2017] 072). The study findings will be presented at international conferences and published in a peer-reviewed journal. This study has been prospectively registered in the Chinese Clinical Trial Registry on September 10, 2018 (ChiCTR1800018290).
应激性心肌病（TTS）是一种急性心力衰竭综合征，其发病前有多种情绪或身体诱因，中枢神经系统疾病是重要诱因之一。远程缺血预处理（RIC）是一种有前景的介入治疗方法，基于TTS和急性冠状动脉综合征可能对干预有相似反应的可能性。RIC的心脏保护作用已在动物模型和观察性临床试验中得到反复证实；然而，在证据水平更高的随机临床试验中，从未对急性卒中后TTS患者进行过研究。本研究将是一项概念验证研究，以确定RIC是否能减少心脏损伤，并最终改善急性卒中后TTS患者的心脏功能和临床结局。将进行一项单中心、结果评估者盲法、随机对照试验（RCT），以评估RIC对急性卒中后TTS患者的疗效。主要入选标准包括经计算机断层扫描或磁共振成像确诊为急性卒中的TTS患者；年龄在18 - 岁至75岁之间；急性卒中发病后48小时内入院的患者；以及InterTAK诊断评分≥50的应激性心肌病患者。总共60名符合条件的患者将被随机分配到RIC组或对照组。主要终点是住院期间以及1个月和6个月随访时任何原因导致的死亡以及主要不良心脑血管事件的复合终点。本研究已获得首都医科大学宣武医院医学伦理委员会批准（[2017] 072）。研究结果将在国际会议上展示，并发表在同行评审期刊上。本研究已于2018年9月10日在中国临床试验注册中心进行前瞻性注册（ChiCTR1800018290）。
