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RECRUITING
NCT04813159
NA

Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Sponsor: University of Cape Town

View on ClinicalTrials.gov

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

DEVICE

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

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