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

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

This study is testing if a treatment called Remote Ischaemic Conditioning can help reduce deaths and heart failure in people with a severe heart attack in Africa.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Cape Town (other)
• Locations: 20 sites (Mombasa, Mombasa County and 19 other locations)
• Trial ID: NCT04813159 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adult patients aged 18 and older presenting with STEMI within 24 hours of myocardial infarction onset.

Not a fit: Patients presenting with STEMI more than 72 hours after onset may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality and heart failure rates in high-risk STEMI patients in Africa.

How similar studies have performed: While previous studies like the CONDI-2/ERIC-PPCI trial did not show success with RIC, this trial focuses on a higher-risk population, making it a novel approach.

Eligibility criteria

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 this trial is running

Mombasa, Mombasa County and 19 other locations

• 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)
• Charlotte Maxeke Hospital — Johannesburg, Gauteng, South Africa (RECRUITING)
• Wentworth Hospital — Durban, KwaZulu-Natal, South Africa (RECRUITING)
• Tshepong Hospital — Klerksdorp, North West, South Africa (RECRUITING)
• Mitchell's Plain District Hospital — Cape Town, Western Cape, South Africa (RECRUITING)
• Groote Schuur Hospital — Cape Town, Western Cape, South Africa (RECRUITING)
• Victoria Hospital — Cape Town, Western Cape, South Africa (RECRUITING)
• George Hospital — George, Western Cape, South Africa (RECRUITING)
• Al Saha Specialised Hospital — Khartoum, Khartoum State, Sudan (RECRUITING)
• Al Shaab Teaching Hospital — Khartoum, Khartoum State, Sudan (RECRUITING)
• Sudan Heart Centre — Khartoum, Khartoum State, Sudan (RECRUITING)
• The Royal Care International Hospital — Khartoum, Khartoum State, Sudan (RECRUITING)
• Aliaa Specialist Hospital — Omdurman, Omdurman, Sudan (RECRUITING)
• Medani Heart Centre — Wad Medani, Sudan (RECRUITING)
• Uganda Heart Institute — Kampala, Kampala, Uganda (RECRUITING)

Study contacts

• Principal investigator: Mpiko Ntsekhe, PhD — University of Cape Town
• Study coordinator: Kishal Lukhna, MBChB

Conditions: STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury, Cardioprotection, Ischaemia/reperfusion injury, ST-Elevation myocardial infarction, Hospitalisation for post-myocardial infarction heart failure, Cardiovascular mortality