Using Remote Ischaemic Conditioning to Improve Outcomes in STEMI Patients in Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The RIC-AFRICA trial is a multi-centre, sham-controlled, randomized controlled trial involving 1400 patients with ST-segment elevation myocardial infarction (STEMI) across seven African countries. It aims to determine if Remote Ischaemic Conditioning (RIC) can reduce all-cause death and early post-myocardial heart failure at 30 days in patients treated predominantly with thrombolytic therapy. Patients will be randomized to receive either RIC or a sham control prior to thrombolysis, with RIC involving cycles of limb ischaemia and reperfusion. The study also includes an observational arm for patients presenting outside the optimal time for thrombolysis.

Why it matters

Who can join: the full rules

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 within 24 hours, will be eligible for the interventional arm of the study if the following inclusion/exclusion criteria are met.

Inclusion Criteria

I. 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.

Exclusion criteria

I. STEMI patients due to undergo primary percutaneous coronary intervention;

II. 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;

III. Contraindications for the use of RIC or sham-control on either arm such as:

1. severe active skin disease/burns on both arms; or
2. bilateral upper limb amputations; or
3. evidence of acute limb ischaemia on either arm; or
4. active upper limb gangrene of any digits;
5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or
6. bilateral arteriovenous fistulae needed for haemodialysis.

IV. Inter-current disease with an expected life expectancy of less than 24 hours;

V. 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.

Inclusion Criteria

I. Signed informed consent; and

II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:

1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and
2. Compatible biomarkers (elevated cardiac troponin); and
3. ECG compatible with recent STEMI; and/or
4. Compatible echocardiography.

Exclusion criteria

I. Refusal or inability to sign informed consent.

Where it's running

• Coast General Teaching Hospital
  Mombasa, Mombasa County, Kenya Recruiting
• Mombasa Hospital
  Mombasa, Mombasa County, Kenya Recruiting
• Kenyatta National Hospital
  Nairobi, Nairobi County, Kenya Recruiting
• Nairobi West hospital
  Nairobi, Kenya Recruiting
• Hospital Central de Mpauto
  Maputo, Mozambique Recruiting
• Hopital Principal de Dakar
  Dakar, Senegal Recruiting

Study contacts

• Principal investigator: Mpiko Ntsekhe, PhD — University of Cape Town
• Study coordinator: Kishal Lukhna, MBChB
• Email: kishallukhna@gmail.com
• Phone: +27732515380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.