Tests remote ischaemic conditioning in heart attack patients across Africa

Trial details

Who runs it

University of Cape Town

Trial code

NCT04813159

Record updated

3 April 2025

Original description

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 predominantly with thrombolytic therapy.Read full original descriptionShow less

Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial

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 predominantly with thrombolytic therapy.

Inclusion: Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads ( ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and/or ≥ 0.1mV in other lead); and II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and III. Signed informed consent; Signed informed consent; and; Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:; Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and; Compatible biomarkers (elevated cardiac troponin); and; ECG compatible with recent STEMI; and/or; Compatible echocardiography.

Exclusion: Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (<12 hours); Observational arm of the study; Patients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion/exclusion criteria are met; severe active skin disease/burns on both arms; or; breast cancer with lymph-node involvement on the ipsilateral side of RIC; or; Inter-current disease with an expected life expectancy of less than 24 hours; STEMI patients presenting with cardiogenic shock or haemodynamic instability as defined by: systolic blood pressure (SBP) measurement of <90 mm Hg for ≥30 minutes; or use of pharmacological and/or mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of <30 mL/h; altered mental status; and/or serum lactate >2.0 mmol/L; STEMI patients due to undergo primary percutaneous coronary intervention; Contraindications for the use of RIC or sham-control on either arm such as:; bilateral upper limb amputations; or; evidence of acute limb ischaemia on either arm; or; active upper limb gangrene of any digits; bilateral arteriovenous fistulae needed for haemodialysis; Refusal or inability to sign informed consent.

We will be recruiting 3 different strata of STEMI patients; 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); 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; 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 within 24 hours, will be eligible for the interventional arm of the study if the following inclusion/exclusion criteria are met.

ClinicalTrials.gov NCT04813159