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

• Published in: Cardiovascular drugs and therapy 2023-04, Vol.37 (2), p.299-305
• Main Authors: Lukhna, Kishal, Hausenloy, Derek J., Ali, Abdelbagi Sidahmed, Bajaber, Abdullah, Calver, Alistair, Mutyaba, Arthur, Mohamed, Awad Abdalla, Kiggundu, Brian, Chishala, Chishala, Variava, Ebrahim, Elmakki, Ehab Ali, Ogola, Elijah, Hamid, Eltayeb, Okello, Emmy, Gaafar, Isam, Mwazo, Keiran, Makotoko, Makoali, Naidoo, Mergan, Abdelhameed, Mohamed Elhadi, Badri, Motasim, van der Schyff, Nasief, Abozaid, Omaima, Xafis, Paul, Giesz, Sara, Gould, Trevor, Welgemoed, Waldo, Walker, Malcolm, Ntsekhe, Mpiko, Yellon, Derek M
• Format: Article
• Language: English
• Subjects: Africa South of the Sahara - epidemiology; Blood pressure; Cardiology; Clinical outcomes; Clinical trials; Conditioning; Congestive heart failure; Double-Blind Method; Heart failure; Heart Failure - etiology; Humans; Ischemia; Ischemia - etiology; Ischemic Preconditioning, Myocardial - methods; Low pressure; Medicine; Medicine & Public Health; Myocardial infarction; Optimization; Pain; Percutaneous Coronary Intervention - adverse effects; Reperfusion; Risk; Size reduction; ST Elevation Myocardial Infarction - diagnosis; ST Elevation Myocardial Infarction - therapy; Therapy; Thrombolysis; Treatment Outcome; Trial Designs
• ISSN: 0920-3206; 1573-7241
• DOI: 10.1007/s10557-021-07283-y

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.