Remote Ischaemic Conditioning in STEMI Patients in AFRICA
- Conditions
- STEMIMyocardial Reperfusion InjuryRemote Ischaemic Conditioning
- Interventions
- Device: Sham-controlDevice: Remote Ischaemic Conditioning (RIC)
- Registration Number
- NCT04813159
- Lead Sponsor
- University of Cape Town
- Brief 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, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham-control 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. Remote Ischaemic Conditioning (RIC) 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.
- Primary Outcome Measures
Name Time Method All-cause death and early post-MI heart failure 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.
- Secondary Outcome Measures
Name Time Method Composite clinical endpoint for MACCE 30 days 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.
Trial Locations
- Locations (20)
Hospital Central de Mpauto
🇲🇿Maputo, Mozambique
Mombasa Hospital
🇰🇪Mombasa, Kenya
Kenyatta National Hospital
🇰🇪Nairobi, Kenya
Nairobi West hospital
🇰🇪Nairobi, Kenya
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, Sudan
Aliaa Specialist Hospital
🇸🇩Omdurman, Sudan
Medani Heart Centre
🇸🇩Wad Medani, Sudan
Uganda Heart Institute
🇺🇬Kampala, Uganda
Hopital Principal de Dakar
🇸🇳Dakar, Senegal
Coast General Teaching Hospital
🇰🇪Mombasa, Kenya