NCT04813159Recruiting
Remote Ischaemic Conditioning in STEMI Patients in AFRICA
Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1400 (estimated)
- First submitted
- 20 Mar 2021
- Start date
- 12 Jan 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Cape Town
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT04813159
What you commit to
- Study type: Interventional
- Planned participants: 1400
- From 12 Jan 2022 to the primary completion date, 31 Dec 2027
- 20 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Lab values
- 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;
Other
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Coast General Teaching Hospital Coordinator of this site? Confirm its status | Mombasa | Kenya | Recruiting |
| Mombasa Hospital Coordinator of this site? Confirm its status | Mombasa | Kenya | Recruiting |
| Nairobi West hospital Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
| Kenyatta National Hospital Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
| Hospital Central de Mpauto Coordinator of this site? Confirm its status | Maputo | Mozambique | Recruiting |
| The Royal Care International Hospital Coordinator of this site? Confirm its status | Khartoum | Sudan | Recruiting |
| Al Shaab Teaching Hospital Coordinator of this site? Confirm its status | Khartoum | Sudan | Recruiting |
| Al Saha Specialised Hospital Coordinator of this site? Confirm its status | Khartoum | Sudan | Recruiting |
| Sudan Heart Centre Coordinator of this site? Confirm its status | Khartoum | Sudan | Recruiting |
| Aliaa Specialist Hospital Coordinator of this site? Confirm its status | Omdurman | Sudan | Recruiting |
| Medani Heart Centre Coordinator of this site? Confirm its status | Wad Medani | Sudan | Recruiting |
| Hopital Principal de Dakar Coordinator of this site? Confirm its status | Dakar | Senegal | Recruiting |
| Uganda Heart Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Mitchell's Plain District Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Victoria Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Groote Schuur Hospital Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Wentworth Hospital Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
| George Hospital Coordinator of this site? Confirm its status | George | South Africa | Recruiting |
| Charlotte Maxeke Hospital Coordinator of this site? Confirm its status | Johannesburg | South Africa | Recruiting |
| Tshepong Hospital Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.