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- Title
Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial.
- 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
- Abstract
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.
- Subjects
AFRICA; ISCHEMIC conditioning; ST elevation myocardial infarction; MYOCARDIAL infarction; SYSTOLIC blood pressure; PERCUTANEOUS coronary intervention
- Publication
Cardiovascular Drugs & Therapy, 2023, Vol 37, Issue 2, p299
- ISSN
0920-3206
- Publication type
Article
- DOI
10.1007/s10557-021-07283-y