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Authors
Madsen, Jasmine Melissa http://orcid.org/0000-0003-2299-7377
Obling, Laust Emil Roelsgaard
Rytoft, Laura
Folke, Fredrik
Hassager, Christian
Andersen, Lars Bredevang
Vejlstrup, Niels
Bang, Lia Evi
Engstrøm, Thomas
Lønborg, Jacob Thomsen
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Funding
Funding for this research was provided by:
Rigshospitalet (E-22670-08)
Royal Library, Copenhagen University Library
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Article History
Received: 23 June 2023
Accepted: 23 November 2023
First Online: 15 December 2023
Declarations
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: Prior to initiation of the trial, the trial was submitted to the Clinical Trials Information System (CTIS) and approved (EU-CT number: 2022–500762-10–00), and it was also submitted to the Danish Data Protection Agency (ID: P-2022–280). The trial is conducted in compliance with the published trial protocol, the Helsinki Declaration, the GCP guidelines (ICH-GCP), and European and national laws. Furthermore, the trial is monitored by the GCP unit of Copenhagen.Due to the acute nature of STEMI and the temporary inability of the patient to provide informed consent in the pre-hospital setting, enrollment and intervention will occur in the pre-hospital setting prior to informed consent. The patient will provide informed consent as soon as possible following the acute initial treatment (primary PCI), once the patient is stable. The informed consent form (ICF) will be filled out and signed by the patient in the encrypted database program REDCap. In patients with STEMI unable to provide informed consent following primary PCI, consent will be obtained by an independent legally designated representative who will sign the ICF. The legally designated representative consent will be followed by informed consent and signature of the ICF by the patient, once the patient is stable and able to provide consent. If the patient remains unable to provide informed consent 3 days following admission, the closest relative to the patient and a legally designated representative will provide consent on behalf of the patient and sign the ICF as soon as possible. The patient will subsequently provide informed consent as soon as possible.
: All consents from the relevant parties (patients, next of kin, legal designated representative) are available upon request. All consent forms have been approved by the authorities prior to initiation of the trial.
: The authors declare that they have no competing interests.
