Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial,Cardiovascular Drugs and Therapy

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Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial
Cardiovascular Drugs and Therapy ( IF 3.4 ) Pub Date : 2021-11-05 , DOI: 10.1007/s10557-021-07283-y
Kishal Lukhna , Derek J. Hausenloy , Abdelbagi Sidahmed Ali , Abdullah Bajaber , Alistair Calver , Arthur Mutyaba , Awad Abdalla Mohamed , Brian Kiggundu , Chishala Chishala , Ebrahim Variava , Ehab Ali Elmakki , Elijah Ogola , Eltayeb Hamid , Emmy Okello , Isam Gaafar , Keiran Mwazo , Makoali Makotoko , Mergan Naidoo , Mohamed Elhadi Abdelhameed , Motasim Badri , Nasief van der Schyff , Omaima Abozaid , Paul Xafis , Sara Giesz , Trevor Gould , Waldo Welgemoed , Malcolm Walker , Mpiko Ntsekhe , Derek M Yellon

Purpose

Despite evidence of myocardial infarct size reduction in animal studies, remote ischaemic conditioning (RIC) failed to improve clinical outcomes in the large CONDI-2/ERIC-PPCI trial. Potential reasons include that the predominantly low-risk study participants all received timely optimal reperfusion therapy by primary percutaneous coronary intervention (PPCI). Whether RIC can improve clinical outcomes in higher-risk STEMI patients in environments with poor access to early reperfusion or PPCI will be investigated in the RIC-AFRICA trial.

Methods

The RIC-AFRICA study is a sub-Saharan African multi-centre, randomized, double-blind, sham-controlled clinical trial designed to test the impact of RIC on the composite endpoint of 30-day mortality and heart failure in 1200 adult STEMI patients without access to PPCI. Randomized participants will be stratified by whether or not they receive thrombolytic therapy within 12 h or arrive outside the thrombolytic window (12–24 h). Participants will receive either RIC (four 5-min cycles of inflation [20 mmHg above systolic blood pressure] and deflation of an automated blood pressure cuff placed on the upper arm) or sham control (similar protocol but with low-pressure inflation of 20 mmHg and deflation) within 1 h of thrombolysis and applied daily for the next 2 days. STEMI patients arriving greater than 24 h after chest pain but within 72 h will be recruited to participate in a concurrently running independent observational arm.

Conclusion

The RIC-AFRICA trial will determine whether RIC can reduce rates of death and heart failure in higher-risk sub-optimally reperfused STEMI patients, thereby providing a low-cost, non-invasive therapy for improving health outcomes.

中文翻译：

撒哈拉以南非洲 STEMI 患者的远程缺血调节：RIC-AFRICA 试验的基本原理和研究设计

目的

尽管在动物研究中有证据表明心肌梗死面积减少，但在大型 CONDI-2/ERIC-PPCI 试验中，远程缺血调节 (RIC) 未能改善临床结果。潜在的原因包括主要的低风险研究参与者都通过直接经皮冠状动脉介入治疗 (PPCI) 及时接受了最佳再灌注治疗。RIC-AFRICA 试验将研究 RIC 是否可以改善早期再灌注或 PPCI 难以获得的环境中高风险 STEMI 患者的临床结果。

方法

RIC-AFRICA 研究是一项撒哈拉以南非洲多中心、随机、双盲、假对照临床试验，旨在测试 RIC 对 1200 名成年 STEMI 患者 30 天死亡率和心力衰竭复合终点的影响无法访问 PPCI。随机参与者将根据他们是否在 12 小时内接受溶栓治疗或到达溶栓窗口（12-24 小时）之外进行分层。参与者将接受 RIC（四个 5 分钟的充气周期 [收缩压以上 20 mmHg] 和放置在上臂上的自动血压袖带放气）或假控制（类似的方案，但低压充气 20 mmHg和放气）在溶栓后 1 小时内，并在接下来的 2 天内每天使用。