Remote Ischaemic Conditioning in STEMI Patients in AFRICA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cape Town
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within <12 hours of most severe chest pain onset).
Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (<12 hours) but within 24 hours of most severe chest pain onset.
Adult patients (≥18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present ≥24 hours and within 72 hours of most severe chest pain onset.
Disqualifiers
severe active skin disease/burns on both arms; or
bilateral upper limb amputations; or
evidence of acute limb ischaemia on either arm; or
active upper limb gangrene of any digits;
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Ischaemic Conditioning (RIC)
DeviceThe 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
DeviceThe 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.
Treatment groups
1,400 Participants
are divided into 3 treatment groupsGroup A: Remote Ischaemic Conditioning (RIC)Active comparator 1 intervention
Group B: Sham-controlSham comparator 1 intervention
Group C: ObservationalNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
All-cause death and early post-MI heart failure
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.
Time frame
30 daysSecondary outcomes
1
Composite clinical endpoint for MACCE
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.
Time frame
30 daysSponsors and contacts
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University of Cape Town
Lead sponsor
Groote Schuur Hospital, South Africa
Collaborator
Uganda Heart Institute
Collaborator
Mombasa Hospital, Kenya
Collaborator
Coast General Teaching Hospital, Kenya
Collaborator
Kenyatta National Hospital
Collaborator
Al Shaab Teaching Hospital, Sudan
Collaborator
Sudan Heart Centre, Sudan
Collaborator
Aliaa Specialist Hospital, Sudan
Collaborator
Medani Heart Centre, Sudan
Collaborator
Al Saha Specialised Hospital, Sudan
Collaborator
Omdurman Hospital, Sudan
Collaborator
Victoria Hospital, South Africa
Collaborator
George Hospital, South Africa
Collaborator
Charlotte Maxeke Hospital, South Africa
Collaborator
Tshepong Hospital, South Africa
Collaborator
Wentworth Hospital, South Africa
Collaborator
Grey's Hospital
Collaborator
Universitas Academic Hospital, South Africa
Collaborator
University College, London
Collaborator
Royal Care international Hospital, Sudan
Collaborator
Nairobi West Hospital, Kenya
Collaborator
Source ClinicalTrials.gov