Remote Ischaemic Conditioning in STEMI Patients in AFRICA
The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda
| Condition(s) | STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients presenting with STEMI and deemed ineligible for the RIC AFRICA RCT because they present \>24 hours from MI onset but less than 72 hours, will be recruited into the observational arm of the study with the same endpoints as the trial. The purpose of the RCT is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated |
| Who can participate | We will be recruiting 3 different strata of STEMI patients. 1. Adult patients (≥18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within \<12 hours of most severe chest pain onset). 2. Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (\<12 hours) but within 24 hours of most severe chest pain onset. 3. Adult patients (≥18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present ≥24 hours and within 72 hours of most severe chest pain onset. Interventional arm of the Study: Randomized Control Trial Patients who are deemed eligible for randomization into the trial on account of presentation with STEMI wi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Cape Town |
| Locations | Mombasa, Mombasa County, Kenya; Mombasa, Mombasa County, Kenya; Nairobi, Nairobi County, Kenya; Nairobi, Kenya; Maputo, Mozambique; Dakar, Senegal (+14 more sites) |
| Start date | 2022-01-12 |
| NCT ID | NCT04813159 |
| Official listing | https://clinicaltrials.gov/study/NCT04813159 |