Remote Ischaemic Conditioning in STEMI Patients in AFRICA (RIC-AFRICA)

March 31, 2025 updated by: Mpiko Ntsekhe, University of Cape Town

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Remote ischaemic conditioning (RIC) using transient limb ischaemia and reperfusion has been shown to reduce myocardial infarct size in animal studies and small proof-of-concept clinical studies in ST-segment elevation myocardial infarction (STEMI) patients. However, RIC failed to improve clinical outcomes in the large European CONDI-2/ERIC-PPCI multi-centre randomised clinical trial. Potential reasons for this failure include the low-risk patients recruited into the study and the fact that patients received timely and optimal reperfusion therapy by primary percutaneous coronary intervention. The RIC-AFRICA trial will investigate whether RIC can improve clinical outcomes in higher-risk STEMI patients treated by thrombolysis in Africa.

Study design:

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 20 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients will be randomised to receive either RIC or sham control initiated prior to thrombolysis and applied daily for the next 2 days. The RIC protocol will comprise four 5-minute cycles of inflation (to 20mmHg above systolic blood pressure) and deflation of an automated pneumatic cuff placed on the upper arm. The sham control protocol will comprise four 5-minute cycles of low-pressure inflation (to 20mmHg) and deflation by a visually identical pneumatic cuff. The primary composite endpoint will be all-cause death and new-onset heart failure at 30-days post STEMI. 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.

Implications:

The RIC-AFRICA trial will determine whether RIC can reduce rates of death and prevent heart failure in higher-risk STEMI patients treated by thrombolytic therapy in Africa, thereby potentially providing a low-cost, non-invasive therapy for improving health outcomes.

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kenya
      • Mombasa, Kenya
        • Recruiting
        • Coast General Teaching Hospital
        • Contact:
        • Contact:
        • Contact:
          • Keiran Mwazo, MBChB
        • Contact:
          • Vickie Mumbo, MBChB
      • Mombasa, Kenya
        • Recruiting
        • Mombasa Hospital
        • Contact:
        • Contact:
          • Abdullah A Bajaber, MBChB
      • Nairobi, Kenya
        • Recruiting
        • Kenyatta National Hospital
        • Contact:
        • Contact:
          • Elijah Ogola, PhD
      • Nairobi, Kenya
        • Recruiting
        • Nairobi West hospital
        • Contact:
        • Contact:
          • Elijah Elijah, PhD
  • Mozambique
      • Maputo, Mozambique
        • Recruiting
        • Hospital Central de Mpauto
        • Contact:
        • Contact:
          • Neusa Jensen
  • Senegal
      • Dakar, Senegal
        • Recruiting
        • Hopital Principal de Dakar
        • Contact:
        • Contact:
          • Cherif Mboup
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Charlotte Maxeke Hospital
        • Contact:
        • Contact:
          • Arthur Mutyab, MBChB
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4026
        • Recruiting
        • Wentworth Hospital
        • Contact:
        • Contact:
          • Mergan Naidoo, PhD
    • North West
      • Klerksdorp, North West, South Africa, 2574
    • Western Cape
      • Cape Town, Western Cape, South Africa, 8000
        • Recruiting
        • Groote Schuur Hospital
        • Contact:
        • Contact:
        • Contact:
          • Kishal Lukhna, MBChB
        • Contact:
          • Mpiko Ntsekhe, PhD
      • Cape Town, Western Cape, South Africa, 8000
        • Recruiting
        • Victoria Hospital
        • Contact:
          • Nasief Van Der Schyff, MBChB
          • Phone Number: +27721910835
          • Email: nasief@gmail.com
        • Contact:
          • Nasief Van Der Schyff, MBChB
      • Cape Town, Western Cape, South Africa, 7785
        • Recruiting
        • Mitchell's Plain District Hospital
        • Contact:
      • George, Western Cape, South Africa, 6530
  • Sudan
      • Khartoum, Sudan
        • Recruiting
        • The Royal Care International Hospital
        • Contact:
        • Contact:
          • Awad A Mohamed, PhD
      • Omdurman, Sudan
        • Recruiting
        • Aliaa Specialist Hospital
        • Contact:
        • Contact:
          • Ehab Ali Elmakki, MBChB
      • Wad Medani, Sudan
        • Recruiting
        • Medani Heart Centre
        • Contact:
        • Contact:
          • Omaima Abozaid, MBChB
    • Khartoum State
      • Khartoum, Khartoum State, Sudan
        • Recruiting
        • Al Saha Specialised Hospital
        • Contact:
        • Contact:
          • Mohamed E Elfadl Abdelhameed, MBChB
      • Khartoum, Khartoum State, Sudan
        • Recruiting
        • Al Shaab Teaching Hospital
        • Contact:
        • Contact:
        • Contact:
          • Awad Mohamed, PhD
        • Contact:
          • Eltayeb Hamid, MBChB
      • Khartoum, Khartoum State, Sudan
        • Recruiting
        • Sudan Heart Centre
        • Contact:
        • Contact:
          • Abdelbagi S Ali, MBChB
  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Uganda Heart Institute
        • Contact:
        • Contact:
        • Contact:
          • Emmy Okello, MBChB
        • Contact:
          • Brian Kiggundu, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

We will be recruiting 3 different strata of STEMI patients.

  1. 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).
  2. 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.
  3. 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.

Interventional arm of the Study: Randomized Control Trial

Patients who are deemed eligible for randomization into the trial on account of presentation with STEMI within 24 hours, will be eligible for the interventional arm of the study if the following inclusion/exclusion criteria are met.

Inclusion Criteria

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.

Exclusion criteria

I. STEMI patients due to undergo primary percutaneous coronary intervention;

II. STEMI patients presenting with cardiogenic shock or haemodynamic instability as defined by: systolic blood pressure (SBP) measurement of <90 mm Hg for ≥30 minutes; or use of pharmacological and/or mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of <30 mL/h; altered mental status; and/or serum lactate >2.0 mmol/L;

III. Contraindications for the use of RIC or sham-control on either arm such as:

  1. severe active skin disease/burns on both arms; or
  2. bilateral upper limb amputations; or
  3. evidence of acute limb ischaemia on either arm; or
  4. active upper limb gangrene of any digits;
  5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or
  6. bilateral arteriovenous fistulae needed for haemodialysis.

IV. Inter-current disease with an expected life expectancy of less than 24 hours;

V. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (<12 hours).

Observational arm of the study

Patients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion/exclusion criteria are met.

Inclusion Criteria

I. Signed informed consent; and

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

  1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and
  2. Compatible biomarkers (elevated cardiac troponin); and
  3. ECG compatible with recent STEMI; and/or
  4. Compatible echocardiography.

Exclusion criteria

I. Refusal or inability to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death and early post-MI heart failure
Time Frame: 30 days
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite clinical endpoint for MACCE
Time Frame: 30 days
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cape Town

Collaborators

University College, London
Kenyatta National Hospital
Uganda Heart Institute
Grey's Hospital
Groote Schuur Hospital, South Africa
Mombasa Hospital, Kenya
Coast General Teaching Hospital, Kenya
Al Shaab Teaching Hospital, Sudan
Sudan Heart Centre, Sudan
Aliaa Specialist Hospital, Sudan
Medani Heart Centre, Sudan
Al Saha Specialised Hospital, Sudan
Omdurman Hospital, Sudan
Victoria Hospital, South Africa
George Hospital, South Africa
Charlotte Maxeke Hospital, South Africa
Tshepong Hospital, South Africa
Wentworth Hospital, South Africa
Universitas Academic Hospital, South Africa
Royal Care international Hospital, Sudan
Nairobi West Hospital, Kenya

Investigators

  • Principal Investigator: Mpiko Ntsekhe, PhD, University of Cape Town
  • Principal Investigator: Derek Hausenloy, PhD, Hatter Cardiovascular Institute
  • Principal Investigator: Derek Yellon, PhD, Hatter Cardiovascular Institute
  • Principal Investigator: Malcolm Walker, PhD, Hatter Cardiovascular Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 20, 2021

First Submitted That Met QC Criteria

March 20, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIC AFRICA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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