Remote Ischaemic Conditioning in STEMI Patients in AFRICA
NCT ID: NCT04813159
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1400 participants
INTERVENTIONAL
2022-01-12
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Sham-control
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.
Sham-control
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.
Observational
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.
No interventions assigned to this group
Interventions
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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.
Sham-control
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.
Eligibility Criteria
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Inclusion Criteria
Interventional arm of the Study: Randomized Control Trial
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.
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
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
I. Refusal or inability to sign informed consent.
18 Years
ALL
No
Sponsors
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Groote Schuur Hospital, South Africa
UNKNOWN
Uganda Heart Institute
OTHER
Mombasa Hospital, Kenya
UNKNOWN
Coast General Teaching Hospital, Kenya
UNKNOWN
Kenyatta National Hospital
OTHER_GOV
Al Shaab Teaching Hospital, Sudan
UNKNOWN
Sudan Heart Centre, Sudan
UNKNOWN
Aliaa Specialist Hospital, Sudan
UNKNOWN
Medani Heart Centre, Sudan
UNKNOWN
Al Saha Specialised Hospital, Sudan
UNKNOWN
Omdurman Hospital, Sudan
UNKNOWN
Victoria Hospital, South Africa
UNKNOWN
George Hospital, South Africa
UNKNOWN
Charlotte Maxeke Hospital, South Africa
UNKNOWN
Tshepong Hospital, South Africa
UNKNOWN
Wentworth Hospital, South Africa
UNKNOWN
Grey's Hospital
OTHER
Universitas Academic Hospital, South Africa
UNKNOWN
University College, London
OTHER
Royal Care international Hospital, Sudan
UNKNOWN
Nairobi West Hospital, Kenya
UNKNOWN
University of Cape Town
OTHER
Responsible Party
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Mpiko Ntsekhe
Professor
Principal Investigators
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Mpiko Ntsekhe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town
Derek Hausenloy, PhD
Role: PRINCIPAL_INVESTIGATOR
Hatter Cardiovascular Institute
Derek Yellon, PhD
Role: PRINCIPAL_INVESTIGATOR
Hatter Cardiovascular Institute
Malcolm Walker, PhD
Role: PRINCIPAL_INVESTIGATOR
Hatter Cardiovascular Institute
Locations
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Coast General Teaching Hospital
Mombasa, Mombasa County, Kenya
Mombasa Hospital
Mombasa, Mombasa County, Kenya
Kenyatta National Hospital
Nairobi, Nairobi County, Kenya
Nairobi West hospital
Nairobi, , Kenya
Hospital Central de Mpauto
Maputo, , Mozambique
Hopital Principal de Dakar
Dakar, , Senegal
Charlotte Maxeke Hospital
Johannesburg, Gauteng, South Africa
Wentworth Hospital
Durban, KwaZulu-Natal, South Africa
Tshepong Hospital
Klerksdorp, North West, South Africa
Mitchell's Plain District Hospital
Cape Town, Western Cape, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, South Africa
Victoria Hospital
Cape Town, Western Cape, South Africa
George Hospital
George, Western Cape, South Africa
Al Saha Specialised Hospital
Khartoum, Khartoum State, Sudan
Al Shaab Teaching Hospital
Khartoum, Khartoum State, Sudan
Sudan Heart Centre
Khartoum, Khartoum State, Sudan
The Royal Care International Hospital
Khartoum, Khartoum State, Sudan
Aliaa Specialist Hospital
Omdurman, Omdurman, Sudan
Medani Heart Centre
Wad Medani, , Sudan
Uganda Heart Institute
Kampala, Kampala, Uganda
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RIC AFRICA
Identifier Type: -
Identifier Source: org_study_id
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