STEMIRIC-AFRICANCT04813159
Remote Ischaemic Conditioning in STEMI Patients in AFRICA
A study testing Remote Ischaemic Conditioning (RIC) in people with STEMI and Remote Ischaemic Conditioning, run by University of Cape Town at 20 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury
- What is being tested?
- Remote Ischaemic Conditioning (RIC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 12 Jan 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- STEMI patients due to undergo primary percutaneous coronary intervention;
- 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;
- Contraindications for the use of RIC or sham-control on either arm such as:
- severe active skin disease/burns on both arms; or
- bilateral upper limb amputations; or
- evidence of acute limb ischaemia on either arm; or
Show all 14Show fewer
- active upper limb gangrene of any digits;
- breast cancer with lymph-node involvement on the ipsilateral side of RIC; or
- bilateral arteriovenous fistulae needed for haemodialysis.
- Inter-current disease with an expected life expectancy of less than 24 hours;
- 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.
- Refusal or inability to sign informed consent.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 6 countries
South Africa7 sites, 7 recruiting
- Recruiting
Mitchell's Plain District Hospital
Cape Town, Western Cape, 7785
Katya Evans, MBCHB, k.evans@uct.ac.za
- Recruiting
Groote Schuur Hospital
Cape Town, Western Cape, 8000
Kishal Lukhna, MBChB, +27732515380, kishallukhna@gmail.com
Mpiko Ntsekhe, PhD, mpiko.ntsekhe@uct.ac.za
- Recruiting
Victoria Hospital
Cape Town, Western Cape, 8000
Nasief Van Der Schyff, MBChB, +27721910835, nasief@gmail.com
Nasief Van Der Schyff, MBChB
- Recruiting
Wentworth Hospital
Durban, KwaZulu-Natal, 4026
Mergan Naidoo, PhD, +27835005334, naidoom@ukzn.ac.za
Mergan Naidoo, PhD
- Recruiting
George Hospital
George, Western Cape, 6530
Trevor Gould, MBChB, +27837741212, trevor.gould@westerncape.gov.za
Trevor Gould, MBChB
- Recruiting
Charlotte Maxeke Hospital
Johannesburg, Gauteng, 2193
Arthur Mutyab, MBChB, +27724267928, akaggwe@yahoo.com
Arthur Mutyab, MBChB
- Recruiting
Tshepong Hospital
Klerksdorp, North West, 2574
Alistair Calver, MBChB, acalver@nwpg.gov.za
Ebrahim Variava, MBChB, variava@worldonline.co.za
Sudan6 sites, 6 recruiting
- Recruiting
Al Saha Specialised Hospital
Khartoum, Khartoum State
Mohamed E Elfadl Abdelhameed, MBChB, Alryanalhadi13@gmail.com
Mohamed E Elfadl Abdelhameed, MBChB
- Recruiting
Al Shaab Teaching Hospital
Khartoum, Khartoum State
Awad Mohamed, PhD, awad90000@gmail.com
Eltayeb Hamid, MBChB, eltayebhamid@yahoo.com
- Recruiting
Sudan Heart Centre
Khartoum, Khartoum State
Abdelbagi S Ali, MBChB, abdelbagisd@gmail.com
Abdelbagi S Ali, MBChB
- Recruiting
The Royal Care International Hospital
Khartoum, Khartoum State
Awad A Mohamed, PhD, awad90000@gmail.com
Awad A Mohamed, PhD
- Recruiting
Aliaa Specialist Hospital
Omdurman, Omdurman
Ehab Ali Elmakki, MBChB, ehabalmakki@gmail.com
Ehab Ali Elmakki, MBChB
- Recruiting
Medani Heart Centre
Wad Medani
Omaima Abozaid, MBChB, Dr.omaima2017@outlook.com
Omaima Abozaid, MBChB
Kenya4 sites, 4 recruiting
- Recruiting
Coast General Teaching Hospital
Mombasa, Mombasa County
Keiran Mwazo, MBChB, kmwasha@yahoo.com
Vickie Mumbo, MBChB, mumbovickie@gmail.com
- Recruiting
Mombasa Hospital
Mombasa, Mombasa County
Abdullah A Bajaber, MBChB, baja1930@gmail.com
Abdullah A Bajaber, MBChB
- Recruiting
Kenyatta National Hospital
Nairobi, Nairobi County
Elijah Ogola, PhD, Elijah.ogola@uonbi.ac.ke
Elijah Ogola, PhD
- Recruiting
Nairobi West hospital
Nairobi
Elijah Elijah, PhD, elijah.ogola@uonbi.ac.ke
Elijah Elijah, PhD
Mozambique1 site, 1 recruiting
- Recruiting
Hospital Central de Mpauto
Maputo
Neusa Jensen, MBCHB, PhD, neusa.jessen@gmail.com
Neusa Jensen
Senegal1 site, 1 recruiting
- Recruiting
Hopital Principal de Dakar
Dakar
Cherif Mboup, MBCHB, PHD, mcmboup@yahoo.fr
Cherif Mboup
Uganda1 site, 1 recruiting
- Recruiting
Uganda Heart Institute
Kampala, Kampala
Emmy Okello, MBChB, emmyoks@gmail.com
Brian Kiggundu, MBChB, makabrian@gmail.com
About this study
Official title: 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.
Read the detailed description
Background:
Remote ischaemic conditioning (RIC) using transient limb ischaemia and reperfusion has been shown to reduce myocardial infarct size in animal studies and small proof-of-concept clinical studies in ST-segment elevation myocardial infarction (STEMI) patients. However, RIC failed to improve clinical outcomes in the large European CONDI-2/ERIC-PPCI multi-centre randomised clinical trial. Potential reasons for this failure include the low-risk patients recruited into the study and the fact that patients received timely and optimal reperfusion therapy by primary percutaneous coronary intervention. The RIC-AFRICA trial will investigate whether RIC can improve clinical outcomes in higher-risk STEMI patients treated by thrombolysis in Africa.
Study design:
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 20 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients will be randomised to receive either RIC or sham control initiated prior to thrombolysis and applied daily for the next 2 days. The RIC protocol will comprise four 5-minute cycles of inflation (to 20mmHg above systolic blood pressure) and deflation of an automated pneumatic cuff placed on the upper arm. The sham control protocol will comprise four 5-minute cycles of low-pressure inflation (to 20mmHg) and deflation by a visually identical pneumatic cuff. The primary composite endpoint will be all-cause death and new-onset heart failure at 30-days post STEMI. 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.
Implications:
The RIC-AFRICA trial will determine whether RIC can reduce rates of death and prevent heart failure in higher-risk STEMI patients treated by thrombolytic therapy in Africa, thereby potentially providing a low-cost, non-invasive therapy for improving health outcomes.
- Being tested
- Remote Ischaemic Conditioning (RIC), Sham-control
- Keywords
- Cardioprotection, Ischaemia/reperfusion injury, ST-Elevation myocardial infarction, Hospitalisation for post-myocardial infarction heart failure, Remote Ischaemic Conditioning, Cardiovascular mortality, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Reperfusion Injury, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic Conditioning (RIC)Device
The RIC protocol will comprise inflation of the automated RIC device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days.
Sham-controlDevice
The sham protocol will comprise low-pressure inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff used in the active arm. The sham control protocol will be repeated daily for the next 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic Conditioning (RIC) | Active comparator | Consented STEMI participants presenting < 24 hours who are randomised to the RIC protocol, will receive blood pressure cuff inflation by the automated RIC blood pressure device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days. Receives: Device: Remote Ischaemic Conditioning (RIC) |
| Sham-control | Sham comparator | Consented STEMI participants presenting < 24 hours who are randomised to the sham protocol will receive low-pressure cuff inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff. The sham control protocol will be repeated daily for the next 2 days. Receives: Device: Sham-control |
| Observational | No intervention | Consented STEMI participants presenting > 24 hours but within 72 hours of MI onset will be recruited into the observational arm of the study which will have the same study endpoints as the RCT. These participants will not be randomised or receive any trial intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death and early post-MI heart failure
The primary endpoint of the study will be a composite of all-cause death and early post-MI heart failure. The latter describes both a] pre-discharge (in-hospital) heart failure; or b] post discharge heart failure hospitalisation within 30 days for patients discharged free of heart failure after the index MI admission.
Measured: 30 days
Secondary outcomes (1)
Composite clinical endpoint for MACCE
Secondary outcome measures will include a composite clinical endpoint of MACCE at 30 days follow-up, defined as rates of (i) all-cause mortality; (ii) non-fatal myocardial infarction; (iii) transient ischaemic attack or stroke; and (iv) heart failure with or without hospitalisation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start12 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consented participants presenting with STEMI within 24 hours and who fulfil the study's eligibility criteria will be assigned a participant identification number and randomised to receive either RIC or sham control in a 1:1 ratio to ensure equal distribution amongst experimental arm. Randomisation will be conducted via a secure website and will be stratified by recruiting centre and patient stratum to ensure that a minimum of 2 participants in stratum 1 (eligible for thrombolysis and within \<12 hours of MI onset) are recruited for every participant in stratum 2 (ineligible for thrombolysis because they present outside of guideline-recommended time (\<12 hours) but presenting within 24 hours of most severe chest pain onset). The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Groote Schuur Hospital, South Africa, Uganda Heart Institute, Mombasa Hospital, Kenya, Coast General Teaching Hospital, Kenya, Kenyatta National Hospital, Al Shaab Teaching Hospital, Sudan, Sudan Heart Centre, Sudan, Aliaa Specialist Hospital, Sudan, Medani Heart Centre, Sudan, Al Saha Specialised Hospital, Sudan, Omdurman Hospital, Sudan, Victoria Hospital, South Africa, George Hospital, South Africa, Charlotte Maxeke Hospital, South Africa, Tshepong Hospital, South Africa, Wentworth Hospital, South Africa, Grey's Hospital, Universitas Academic Hospital, South Africa, University College, London, Royal Care international Hospital, Sudan, Nairobi West Hospital, Kenya
- Responsible party
- Principal investigator, Mpiko Ntsekhe, University of Cape Town
- Investigators
- Mpiko Ntsekhe, PhD, Principal investigator, University of Cape TownDerek Hausenloy, PhD, Principal investigator, Hatter Cardiovascular InstituteDerek Yellon, PhD, Principal investigator, Hatter Cardiovascular InstituteMalcolm Walker, PhD, Principal investigator, Hatter Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813159
- Sponsor's protocol ID
- RIC AFRICA
- Acronym
- RIC-AFRICA
- Status last verified
- Dec 2024
- First submitted
- 20 Mar 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lukhna K, Hausenloy DJ, Ali AS, Bajaber A, Calver A, Mutyaba A, Mohamed AA, Kiggundu B, Chishala C, Variava E, Elmakki EA, Ogola E, Hamid E, Okello E, Gaafar I, Mwazo K, Makotoko M, Naidoo M, Abdelhameed ME, Badri M, van der Schyff N, Abozaid O, Xafis P, Giesz S, Gould T, Welgemoed W, Walker M, Ntsekhe M, Yellon DM. Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial. Cardiovasc Drugs Ther. 2023 Apr;37(2):299-305. doi: 10.1007/s10557-021-07283-y. Epub 2021 Nov 5.
PubMed 34739648
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial
- ClinicalTrials.gov ID
- NCT04813159
- Acronym / sponsor ID
- RIC-AFRICA / RIC AFRICA
- Keywords
- Cardioprotection, Ischaemia/reperfusion injury, ST-Elevation myocardial infarction, Hospitalisation for post-myocardial infarction heart failure, Remote Ischaemic Conditioning, Cardiovascular mortality, STEMI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Groote Schuur Hospital, South Africa, Uganda Heart Institute, Mombasa Hospital, Kenya, Coast General Teaching Hospital, Kenya, Kenyatta National Hospital, Al Shaab Teaching Hospital, Sudan, Sudan Heart Centre, Sudan, Aliaa Specialist Hospital, Sudan, Medani Heart Centre, Sudan, Al Saha Specialised Hospital, Sudan, Omdurman Hospital, Sudan, Victoria Hospital, South Africa, George Hospital, South Africa, Charlotte Maxeke Hospital, South Africa, Tshepong Hospital, South Africa, Wentworth Hospital, South Africa, Grey's Hospital, Universitas Academic Hospital, South Africa, University College, London, Royal Care international Hospital, Sudan, Nairobi West Hospital, Kenya
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Remote ischaemic conditioning (RIC) using transient limb ischaemia and reperfusion has been shown to reduce myocardial infarct size in animal studies and small proof-of-concept clinical studies in ST-segment elevation myocardial infarction (STEMI) patients. However, RIC failed to improve clinical outcomes in the large European CONDI-2/ERIC-PPCI multi-centre randomised clinical trial. Potential reasons for this failure include the low-risk patients recruited into the study and the fact that patients received timely and optimal reperfusion therapy by primary percutaneous coronary intervention. The RIC-AFRICA trial will investigate whether RIC can improve clinical outcomes in higher-risk STEMI patients treated by thrombolysis in Africa.
Study design:
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 20 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients will be randomised to receive either RIC or sham control initiated prior to thrombolysis and applied daily for the next 2 days. The RIC protocol will comprise four 5-minute cycles of inflation (to 20mmHg above systolic blood pressure) and deflation of an automated pneumatic cuff placed on the upper arm. The sham control protocol will comprise four 5-minute cycles of low-pressure inflation (to 20mmHg) and deflation by a visually identical pneumatic cuff. The primary composite endpoint will be all-cause death and new-onset heart failure at 30-days post STEMI. 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.
Implications:
The RIC-AFRICA trial will determine whether RIC can reduce rates of death and prevent heart failure in higher-risk STEMI patients treated by thrombolytic therapy in Africa, thereby potentially providing a low-cost, non-invasive therapy for improving health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Consented participants presenting with STEMI within 24 hours and who fulfil the study's eligibility criteria will be assigned a participant identification number and randomised to receive either RIC or sham control in a 1:1 ratio to ensure equal distribution amongst experimental arm. Randomisation will be conducted via a secure website and will be stratified by recruiting centre and patient stratum to ensure that a minimum of 2 participants in stratum 1 (eligible for thrombolysis and within <12 hours of MI onset) are recruited for every participant in stratum 2 (ineligible for thrombolysis because they present outside of guideline-recommended time (<12 hours) but presenting within 24 hours of most severe chest pain onset). The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial.
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic Conditioning (RIC) | Active comparator | Device: Remote Ischaemic Conditioning (RIC)Consented STEMI participants presenting < 24 hours who are randomised to the RIC protocol, will receive blood pressure cuff inflation by the automated RIC blood pressure device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days. |
| Sham-control | Sham comparator | Device: Sham-controlConsented STEMI participants presenting < 24 hours who are randomised to the sham protocol will receive low-pressure cuff inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff. The sham control protocol will be repeated daily for the next 2 days. |
| Observational | No intervention | –Consented STEMI participants presenting > 24 hours but within 72 hours of MI onset will be recruited into the observational arm of the study which will have the same study endpoints as the RCT. These participants will not be randomised or receive any trial intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- STEMI patients due to undergo primary percutaneous coronary intervention;
- 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;
- Contraindications for the use of RIC or sham-control on either arm such as:
- severe active skin disease/burns on both arms; or
- bilateral upper limb amputations; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Ischaemic Conditioning (RIC)The RIC protocol will comprise inflation of the automated RIC device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days. | Device | Remote Ischaemic Conditioning (RIC) |
| Sham-controlThe sham protocol will comprise low-pressure inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff used in the active arm. The sham control protocol will be repeated daily for the next 2 days. | Device | Sham-control |
Primary outcome
All-cause death and early post-MI heart failure
Time frame: 30 days
The primary endpoint of the study will be a composite of all-cause death and early post-MI heart failure. The latter describes both a] pre-discharge (in-hospital) heart failure; or b] post discharge heart failure hospitalisation within 30 days for patients discharged free of heart failure after the index MI admission.
1 secondary outcome
Composite clinical endpoint for MACCE
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 34739648Lukhna K, Hausenloy DJ, Ali AS, Bajaber A, Calver A, Mutyaba A, Mohamed AA, Kiggundu B, Chishala C, Variava E, Elmakki EA, Ogola E, Hamid E, Okello E, Gaafar I, Mwazo K, Makotoko M, Naidoo M, Abdelhameed ME, Badri M, van der Schyff N, Abozaid O, Xafis P, Giesz S, Gould T, Welgemoed W, Walker M, Ntsekhe M, Yellon DM. Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial. Cardiovasc Drugs Ther. 2023 Apr;37(2):299-305. doi: 10.1007/s10557-021-07283-y. Epub 2021 Nov 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mpiko Ntsekhe, PhD principal investigator
University of Cape Town
Derek Hausenloy, PhD principal investigator
Hatter Cardiovascular Institute
Derek Yellon, PhD principal investigator
Hatter Cardiovascular Institute
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning (RIC) in people with STEMI and Remote Ischaemic Conditioning, run by University of Cape Town at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Africa, Sudan, Kenya, Mozambique, Senegal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kishal Lukhna, MBChB (+27732515380, kishallukhna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death and early post-MI heart failure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.