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

Autor: Lukhna K; Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Hausenloy DJ; The Hatter Cardiovascular Institute, University College London, London, UK.; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore, Singapore.; National Heart Research Institute Singapore, National Heart Centre, Singapore, Singapore.; Yong Loo Lin School of Medicine, National University Singapore, Singapore, Singapore.; Cardiovascular Research Center, College of Medical and Health Sciences, Asia University, Taichung, Taiwan., Ali AS; Sudan Heart Centre, Khartoum, Sudan., Bajaber A; Mombasa hospital, Mombasa, Kenya., Calver A; Tshepong Hospital, Klerksdorp, South Africa., Mutyaba A; Division of Cardiology, Charlotte Maxeke Johannesburg Academic Hospital and University of Witwatersrand, Johannesburg, Gauteng, South Africa., Mohamed AA; Al Shaab Teaching Hospital, Khartoum, Sudan.; Royal Care International Hospital, Khartoum, Sudan., Kiggundu B; Uganda Heart Institute, Kampala, Uganda., Chishala C; Division of Cardiology, Greys Hospital and University of KwaZulu Natal, Pietermaritzburg, South Africa., Variava E; Tshepong Hospital, Klerksdorp, South Africa., Elmakki EA; Aliaa Specialist Hospital, Omdurman, Sudan., Ogola E; Kenyatta National Hospital, Nairobi, Kenya., Hamid E; Al Shaab Teaching Hospital, Khartoum, Sudan., Okello E; Uganda Heart Institute, Kampala, Uganda., Gaafar I; Omdurman Accident and Emergency Hospital, Khartoum, Sudan., Mwazo K; Coast General Teaching Hospital, Mombasa, Kenya., Makotoko M; Division of Cardiology, Universitas Academic Hospital, Bloemfontein, South Africa., Naidoo M; Division of Family Medicine, Wentworth Hospital, University of KwaZulu Natal, Durban, South Africa., Abdelhameed ME; Al Saha Specialised Hospital, Khartoum, Sudan., Badri M; Department of Epidemiology and Biostatistics, King Saud Bin Abdulaziz University for Health Sciences, University of Riyadh, Riyadh, Saudi Arabia., van der Schyff N; Victoria Hospital, University of Cape Town, Cape Town, South Africa., Abozaid O; Medani Heart Centre, Wad Medani, Sudan., Xafis P; Victoria Hospital, University of Cape Town, Cape Town, South Africa., Giesz S; The Hatter Cardiovascular Institute, University College London, London, UK., Gould T; Department of Medicine, George Hospital, George, South Africa., Welgemoed W; Department of Medicine, George Hospital, George, South Africa., Walker M; The Hatter Cardiovascular Institute, University College London, London, UK., Ntsekhe M; Division of Cardiology, Groote Schuur Hospital and Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa., Yellon DM; The Hatter Cardiovascular Institute, University College London, London, UK. d.yellon@ucl.ac.uk.
Jazyk: angličtina
Zdroj: Cardiovascular drugs and therapy [Cardiovasc Drugs Ther] 2023 Apr; Vol. 37 (2), pp. 299-305. Date of Electronic Publication: 2021 Nov 05.
DOI: 10.1007/s10557-021-07283-y
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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