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Remote Ischaemic Conditioning in STEMI Patients in AFRICA
Sponsor: University of Cape Town
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.
Official title: Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1400
Start Date
2022-01-12
Completion Date
2027-12-31
Last Updated
2025-04-03
Healthy Volunteers
No
Interventions
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.
Locations (20)
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