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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ I. Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads ( ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and/or ≥ 0.1mV in other lead); and II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and III. Signed informed consent.

⁃ I. Signed informed consent; and

⁃ II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:

• Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and

• Compatible biomarkers (elevated cardiac troponin); and

• ECG compatible with recent STEMI; and/or

• Compatible echocardiography.

Locations
Other Locations
Kenya
Coast General Teaching Hospital
RECRUITING
Mombasa
Mombasa Hospital
RECRUITING
Mombasa
Kenyatta National Hospital
RECRUITING
Nairobi
Nairobi West hospital
RECRUITING
Nairobi
Mozambique
Hospital Central de Mpauto
RECRUITING
Maputo
Senegal
Hopital Principal de Dakar
RECRUITING
Dakar
South Africa
Groote Schuur Hospital
RECRUITING
Cape Town
Mitchell's Plain District Hospital
RECRUITING
Cape Town
Victoria Hospital
RECRUITING
Cape Town
Wentworth Hospital
RECRUITING
Durban
George Hospital
RECRUITING
George
Charlotte Maxeke Hospital
RECRUITING
Johannesburg
Tshepong Hospital
RECRUITING
Klerksdorp
Sudan
Al Saha Specialised Hospital
RECRUITING
Khartoum
Al Shaab Teaching Hospital
RECRUITING
Khartoum
Sudan Heart Centre
RECRUITING
Khartoum
The Royal Care International Hospital
RECRUITING
Khartoum
Aliaa Specialist Hospital
RECRUITING
Omdurman
Medani Heart Centre
RECRUITING
Wad Medani
Uganda
Uganda Heart Institute
RECRUITING
Kampala
Contact Information
Primary
Kishal Lukhna, MBChB
kishallukhna@gmail.com
+27732515380
Backup
Sara Giesz
s.giesz@ucl.ac.uk
+44(0)20 3447 9888
Time Frame
Start Date: 2022-01-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1400
Treatments
Active_comparator: Remote Ischaemic Conditioning (RIC)
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_comparator: Sham-control
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.
No_intervention: Observational
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.
Authors
Isam Jaffar
Related Therapeutic Areas
Sponsors
Collaborators: Uganda Heart Institute, Grey's Hospital, Kenyatta National Hospital, Al Shaab Teaching Hospital, Sudan, University College, London, Charlotte Maxeke Hospital, South Africa, Tshepong Hospital, South Africa, Royal Care international Hospital, Sudan, George Hospital, South Africa, Groote Schuur Hospital, South Africa, Medani Heart Centre, Sudan, Coast General Teaching Hospital, Kenya, Mombasa Hospital, Kenya, Universitas Academic Hospital, South Africa, Wentworth Hospital, South Africa, Aliaa Specialist Hospital, Sudan, Nairobi West Hospital, Kenya, Sudan Heart Centre, Sudan, Al Saha Specialised Hospital, Sudan, Omdurman Hospital, Sudan, Victoria Hospital, South Africa
Leads: University of Cape Town

This content was sourced from clinicaltrials.gov