Lukhna, Kishal
Hausenloy, Derek J.
Ali, Abdelbagi Sidahmed
Bajaber, Abdullah
Calver, Alistair
Mutyaba, Arthur
Mohamed, Awad Abdalla
Kiggundu, Brian
Chishala, Chishala
Variava, Ebrahim
Elmakki, Ehab Ali
Ogola, Elijah
Hamid, Eltayeb
Okello, Emmy
Gaafar, Isam
Mwazo, Keiran
Makotoko, Makoali
Naidoo, Mergan
Abdelhameed, Mohamed Elhadi
Badri, Motasim
van der Schyff, Nasief
Abozaid, Omaima
Xafis, Paul
Giesz, Sara
Gould, Trevor
Welgemoed, Waldo
Walker, Malcolm
Ntsekhe, Mpiko
Yellon, Derek M http://orcid.org/0000-0001-7791-9320
Article History
Accepted: 25 October 2021
First Online: 5 November 2021
Declarations
:
: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Human Research Ethics Committee of the Faculty of Health Science, University of Cape Town (HREC107/2021).
: The authors affirm that informed consent will be obtained from all individual participants included in this study. Consent forms have been approved by the Human Research Ethics Committee, University of Cape Town, South Africa. As practised in most modern-day STEMI trials, the RIC-AFRICA trial will offer an option for deferred consent for patients assessed to have impaired decision-making capacity. The study investigators, after providing adequate information about the trial, will assess the patient’s capacity to comprehend study-related information and provide written consent. Those found to be incompetent to sign consent, a next-of-kin designated by the patient will be telephonically contacted to perform the role of proxy and provide verbal witnessed informed consent prior to randomization, which will be complemented by written consent as soon as the patient regains full capacity to do so. Clinically stable, pain-free participants deemed capable of providing written consent will consent at STEMI presentation. All participants who speak local languages other than English will have access to certified translated information leaflets and consent forms. Patients who are confused, incoherent, complicated with pulmonary oedema, or found to be haemodynamically unstable will not be recruited into the RIC-AFRICA trial. Patients will be informed that participation is voluntary and that they can withdraw from the study at any time, without prejudice.
: The authors affirm that all data collected, analysed, and published will be free from any participant identifying details. In addition, consent for the publication of anonymised data will be obtained from all individual participants included in this study before study recruitment. This study will comply with the Data Sharing Policy, and as such, this trial was registered with ExternalRef removed (identifier: NCT04813159). All attempts will be made to publish the results in peer-reviewed journals. The Trial Steering Committee is responsible for reporting and publishing the results of the study. The results of the study will be submitted for publication regardless of whether the study outcomes are achieved.
: The authors declare no competing interests.