Tests remote ischaemic conditioning in heart attack patients across Africa

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a heart attack of the STEMI type who arrive within 24 hours of the start of the attack. Adults who arrive 24 to 72 hours after it can join a separate observation-only part.

Age

18 years or older

Sex

All sexes

Disease stage

STEMI (a heart attack with ST-segment elevation on the ECG). For the randomised part: within 24 hours of the start of the heart attack. For the observation-only part: more than 24 hours and less than 72 hours after the start.

Earlier treatment

Patients who arrive within 12 hours are expected to receive thrombolytic (clot-dissolving) treatment. Patients who arrive between 12 and 24 hours are not given thrombolysis.

Biomarker or test result

Observation-only part: raised cardiac troponin (a heart injury blood marker) is one of the signs of a STEMI older than 24 hours.

Main reasons for not taking part

• Due to have primary percutaneous coronary intervention (a procedure to open the blocked artery)
• Cardiogenic shock or unstable blood pressure with signs of organ damage
• Conditions that make the arm cuff treatment unsafe, such as severe skin disease or burns on both arms, or amputation of both arms
• Expected to live less than 24 hours because of another illness
• Cannot have thrombolytic treatment (for those who arrive within 12 hours)

The registry criteria, word for word

What the trial wants to find out

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.

The 3 groups in the trial

• Remote Ischaemic Conditioning (RIC)Existing treatment, for comparison

  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.

• Sham-controlSham treatment, for comparison

  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.

• ObservationalNo study treatment, for comparison

  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.