NCT04813159

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
6 countries

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2022Dec 2027

First Submitted

Initial submission to the registry

March 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 3, 2025

Status Verified

December 1, 2024

Enrollment Period

6 years

First QC Date

March 20, 2021

Last Update Submit

March 31, 2025

Conditions

STEMIRemote Ischaemic ConditioningMyocardial Reperfusion Injury

Keywords

CardioprotectionIschaemia/reperfusion injuryST-Elevation myocardial infarctionHospitalisation for post-myocardial infarction heart failureRemote Ischaemic ConditioningCardiovascular mortalitySTEMI

Outcome Measures

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.

    30 days

Secondary Outcomes (1)

  • Composite clinical endpoint for MACCE

    30 days

Study Arms (3)

Remote Ischaemic Conditioning (RIC)

ACTIVE COMPARATOR

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)

Sham-control

SHAM COMPARATOR

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

Observational

NO INTERVENTION

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.

Interventions

Remote Ischaemic Conditioning (RIC)DEVICE

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.

Remote Ischaemic Conditioning (RIC)
Sham-controlDEVICE

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.

Sham-control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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. 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:
  • 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;
  • breast cancer with lymph-node involvement on the ipsilateral side of RIC; or
  • 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
  • I. Signed informed consent; and
  • II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Coast General Teaching Hospital

Mombasa, Mombasa County, Kenya

RECRUITING

Mombasa Hospital

Mombasa, Mombasa County, Kenya

RECRUITING

Kenyatta National Hospital

Nairobi, Nairobi County, Kenya

RECRUITING

Nairobi West hospital

Nairobi, Kenya

RECRUITING

Hospital Central de Mpauto

Maputo, Mozambique

RECRUITING

Hopital Principal de Dakar

Dakar, Senegal

RECRUITING

Charlotte Maxeke Hospital

Johannesburg, Gauteng, 2193, South Africa

RECRUITING

Wentworth Hospital

Durban, KwaZulu-Natal, 4026, South Africa

RECRUITING

Tshepong Hospital

Klerksdorp, North West, 2574, South Africa

RECRUITING

Mitchell's Plain District Hospital

Cape Town, Western Cape, 7785, South Africa

RECRUITING

Groote Schuur Hospital

Cape Town, Western Cape, 8000, South Africa

RECRUITING

Victoria Hospital

Cape Town, Western Cape, 8000, South Africa

RECRUITING

George Hospital

George, Western Cape, 6530, South Africa

RECRUITING

Al Saha Specialised Hospital

Khartoum, Khartoum State, Sudan

RECRUITING

Al Shaab Teaching Hospital

Khartoum, Khartoum State, Sudan

RECRUITING

Sudan Heart Centre

Khartoum, Khartoum State, Sudan

RECRUITING

The Royal Care International Hospital

Khartoum, Khartoum State, Sudan

RECRUITING

Aliaa Specialist Hospital

Omdurman, Omdurman, Sudan

RECRUITING

Medani Heart Centre

Wad Medani, Sudan

RECRUITING

Uganda Heart Institute

Kampala, Kampala, Uganda

RECRUITING

Related Publications (1)

  • Lukhna K, Hausenloy DJ, Ali AS, Bajaber A, Calver A, Mutyaba A, Mohamed AA, Kiggundu B, Chishala C, Variava E, Elmakki EA, Ogola E, Hamid E, Okello E, Gaafar I, Mwazo K, Makotoko M, Naidoo M, Abdelhameed ME, Badri M, van der Schyff N, Abozaid O, Xafis P, Giesz S, Gould T, Welgemoed W, Walker M, Ntsekhe M, Yellon DM. Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial. Cardiovasc Drugs Ther. 2023 Apr;37(2):299-305. doi: 10.1007/s10557-021-07283-y. Epub 2021 Nov 5.

    PMID: 34739648BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial Reperfusion InjuryReperfusion Injury

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCardiomyopathiesPostoperative Complications

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kishal Lukhna, MBChB

CONTACT

+27732515380kishallukhna@gmail.com

Sara Giesz

CONTACT

+44(0)20 3447 9888s.giesz@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Consented participants presenting with STEMI within 24 hours and who fulfil the study's eligibility criteria will be assigned a participant identification number and randomised to receive either RIC or sham control in a 1:1 ratio to ensure equal distribution amongst experimental arm. Randomisation will be conducted via a secure website and will be stratified by recruiting centre and patient stratum to ensure that a minimum of 2 participants in stratum 1 (eligible for thrombolysis and within \<12 hours of MI onset) are recruited for every participant in stratum 2 (ineligible for thrombolysis because they present outside of guideline-recommended time (\<12 hours) but presenting within 24 hours of most severe chest pain onset). The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2021

First Posted

March 24, 2021

Study Start

January 12, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 3, 2025

Record last verified: 2024-12

Locations

SE(1)KE(4)ZA(7)SU(6)MO(1)UG(1)