Remote Ischaemic Conditioning in STEMI Patients in AFRICA

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.

Conditions

• STEMI
• Remote Ischaemic Conditioning
• Myocardial Reperfusion Injury

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.

Sponsors & Collaborators

• Groote Schuur Hospital, South Africa

  collaborator UNKNOWN

• Uganda Heart Institute

  collaborator OTHER

• Mombasa Hospital, Kenya

  collaborator UNKNOWN

• Coast General Teaching Hospital, Kenya

  collaborator UNKNOWN

• Kenyatta National Hospital

  collaborator OTHER_GOV

• Al Shaab Teaching Hospital, Sudan

  collaborator UNKNOWN

• Sudan Heart Centre, Sudan

  collaborator UNKNOWN

• Aliaa Specialist Hospital, Sudan

  collaborator UNKNOWN

• Medani Heart Centre, Sudan

  collaborator UNKNOWN

• Al Saha Specialised Hospital, Sudan

  collaborator UNKNOWN

• Omdurman Hospital, Sudan

  collaborator UNKNOWN

• Victoria Hospital, South Africa

  collaborator UNKNOWN

• George Hospital, South Africa

  collaborator UNKNOWN

• Charlotte Maxeke Hospital, South Africa

  collaborator UNKNOWN

• Tshepong Hospital, South Africa

  collaborator UNKNOWN

• Wentworth Hospital, South Africa

  collaborator UNKNOWN

• Grey's Hospital

  collaborator OTHER

• Universitas Academic Hospital, South Africa

  collaborator UNKNOWN

• University College, London

  collaborator OTHER

• Royal Care international Hospital, Sudan

  collaborator UNKNOWN

• Nairobi West Hospital, Kenya

  collaborator UNKNOWN

• University of Cape Town

  lead OTHER

Principal Investigators

• Mpiko Ntsekhe, PhD · University of Cape Town

• Derek Hausenloy, PhD · Hatter Cardiovascular Institute

• Derek Yellon, PhD · Hatter Cardiovascular Institute

• Malcolm Walker, PhD · Hatter Cardiovascular Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-12

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Kenya
• Mozambique
• Senegal
• South Africa
• Sudan
• Uganda

Study Locations