RecruitingNot ApplicableNCT04813159

Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial


Sponsor

University of Cape Town

Enrollment

1,400 participants

Start Date

Jan 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a simple, non-invasive technique called remote ischaemic conditioning (RIC) — which involves briefly squeezing the arm with a blood pressure cuff to protect the heart — can reduce heart damage and improve outcomes in people in Africa who are having a heart attack (STEMI). **You may be eligible if...** - You are 18 or older - You are having a heart attack (STEMI — a specific type where a major artery is fully blocked) - You are either: receiving a clot-dissolving drug within 12 hours of chest pain onset, OR arriving too late for that drug, OR waiting for an emergency heart procedure (primary PCI) **You may NOT be eligible if...** - You have severe arm injuries or conditions preventing safe use of the blood pressure cuff - You are in cardiogenic shock (heart is too weak to pump blood) - You have had a recent prior heart attack - You are unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemote 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.

DEVICESham-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

View Full Details on ClinicalTrials.gov

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NCT04813159


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