Department of Anaesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
BMJ Open. 2023 Jun 23;13(6):e073038. doi: 10.1136/bmjopen-2023-073038.
Myocardial injury after non-cardiac surgery (MINS) caused by an ischaemic mechanism is common and is associated with adverse short-term and long-term prognoses. However, MINS is a recent concept, and few studies have prospectively used it as a primary outcome. Remote ischaemic preconditioning (RIPC) is a non-invasive procedure that induces innate cardioprotection and may reduce MINS.
This is a multicentre, randomised, sham-controlled, observer-blinded trial. Patients with a high clinical risk of cardiovascular events who are scheduled to undergo major abdominal surgery will be enrolled. A total of 766 participants will be randomised (1:1 ratio) to receive RIPC or control treatment before anaesthesia. RIPC will comprise four cycles of cuff inflation for 5 min to 200 mm Hg and deflation for 5 min. In the controls, an identical-looking cuff will be placed around the arm but will not be actually inflated. The primary outcome will be MINS, defined as at least one postoperative cardiac troponin (cTn) concentration above the 99th percentile upper reference limit of the cTn assay as a result of a presumed ischaemic mechanism. This trial will test the concentration of high-sensitivity cardiac troponin T (hs-cTnT). The secondary outcomes will be hs-cTnT levels reaching/above the prognostically important thresholds, peak hs-cTnT and total hs-cTnT release during the initial 3 days after surgery, length of hospital stay after surgery, length of stay in the intensive care unit, myocardial infarction, major adverse cardiovascular events, cardiac-related death, all-cause death within 30 days, 6 months, 1 year and 2 years after surgery, and postoperative complications and adverse events within 30 days after surgery.
This study protocol (version 5.0 on 7 April 2023) was approved by the Ethics Committee of Sixth Affiliated Hospital of Sun Yat-sen University. The findings will be published in peer-reviewed journals.
NCT05733208.
非心脏手术后心肌损伤（MINS）是一种常见的缺血性机制引起的疾病，与短期和长期预后不良相关。然而，MINS 是一个较新的概念，很少有研究前瞻性地将其作为主要结局。远程缺血预处理（RIPC）是一种非侵入性的程序，可诱导内在的心脏保护作用，可能减少 MINS。
这是一项多中心、随机、假对照、观察者盲法试验。将招募计划接受大腹部手术的心血管事件高危患者。共纳入 766 例患者（1:1 比例），在麻醉前随机分为 RIPC 组或对照组。RIPC 将包括四个周期的袖带充气 5 分钟至 200mmHg 并放气 5 分钟。在对照组中，将在手臂周围放置一个看起来相同的袖带，但实际上不会充气。主要结局将是 MINS，定义为由于假定的缺血机制，术后至少一次心脏肌钙蛋白（cTn）浓度超过 cTn 检测的 99 百分位上限。本试验将检测高敏心肌肌钙蛋白 T（hs-cTnT）的浓度。次要结局将是 hs-cTnT 水平达到/高于预后重要阈值、术后 3 天内 hs-cTnT 峰值和总 hs-cTnT 释放、术后住院时间、重症监护病房住院时间、心肌梗死、主要不良心血管事件、与心脏相关的死亡、术后 30 天、6 个月、1 年和 2 年内的全因死亡、术后 30 天内的术后并发症和不良事件。
本研究方案（2023 年 4 月 7 日第 5.0 版）已获得中山大学附属第六医院伦理委员会的批准。研究结果将发表在同行评议的期刊上。
NCT05733208。
