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Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Study acronym: RIC-AFRICA
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027v7 Show 5 more changesShow less
    • Enrollment target: 1200 to 1400
    • Study sites: 18 to 20
    • Publications: details revised at 1 of 1 entry
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word
  2. Primary and study completion dates: Mar 31, 2024 to Dec 31, 2025
    • Study sites: 20 to 18
    • Study description expanded, about 1 word
    v6
  3. Site details revised at 6 of 20 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Oct 2023 to Mar 31, 2024
    • Start date changed from estimate of Oct 2021 to Jan 12, 2022
    • Site details revised at 20 of 20 sites
    v4
  5. Start date: May 2021 to Oct 2021v3 Show 7 more changesShow less
    • Study sites: 19 to 20
    • Primary and study completion dates: May 2023 to Oct 2023
    • Eligibility criteria expanded, about 315 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 33 words
    • Collaborators: 20 to 21
    • Study arms: 2 to 3
  6. Study sites: 18 to 19
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
    • Collaborators: 19 to 20
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04813159
Lead Sponsor University of Cape Town
Collaborators: Groote Schuur Hospital, South Africa, Uganda Heart Institute, Mombasa Hospital, Kenya, Coast General Teaching Hospital, Kenya, Kenyatta National Hospital, 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, Grey's Hospital, Universitas Academic Hospital, South Africa, University College, London, Royal Care international Hospital, Sudan, Nairobi West Hospital, Kenya
Conditions
(from sponsor)		 STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury
Related terms Myocardial Reperfusion Injury, Reperfusion Injury, ST Elevation Myocardial Infarction
Enrollment 1,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov