Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial.
Cardiovasc Drugs Ther
; 37(2): 299-305, 2023 04.
Article
em En
| MEDLINE
| ID: mdl-34739648
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Precondicionamento Isquêmico Miocárdico
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Intervenção Coronária Percutânea
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Infarto do Miocárdio com Supradesnível do Segmento ST
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Insuficiência Cardíaca
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Humans
País como assunto:
Africa
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article