Administrative information
Title {1} | Pre-hospital Pulse Glucocorticoid Therapy in Patients with ST-Segment Elevation Myocardial Infarction Transferred for Primary Percutaneous Coronary Intervention: A Randomized Clinical Trial (PULSE-MI) |
Trial registration {2a and 2b}. | EU-CT number: 2022–500762-10–00; ClinicalTrials.gov Identifier: NCT05462730 |
Protocol version {3} | Version: 4.0 of March 8, 2023 |
Funding {4} | The study is supported by the Clinical Research Unit, Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark. JMMs and LOs salary is supported by the Rigshospitalet Research Foundation (E-22670–08) and (E-22652–04). FF has received research grant from Novo Nordisk Foundation (NNF19OC0055142). LRs salary is supported by Novo Nordisk Foundation (NNF18OC034384). |
Author details {5a} | JMM, LO, LR, CH, NV, LB, TE, JL: Department of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark FF: Copenhagen Emergency Medical Services, University of Copenhagen, Copenhagen, Denmark, and Department of Cardiology, Copenhagen University Hospital Herlev, Copenhagen Denmark LA: Region Zealand Emergency Medical Services, Naestved, Denmark |
Name and contact information for the trial sponsor {5b} | Thomas Engstrøm, Professor, MD, PhD, DMSc, Dept. of Cardiology, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark Email: Thomas.engstroem@regionh.dk |
Role of sponsor {5c} | The sponsor maintains authority over all aspects of the trial including design, management, interpretation of results and publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Primary objective
Secondary objective
Hypothesis
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
CMR imaging
Image analysis
Participant timeline {13}
Study period | ||||||
---|---|---|---|---|---|---|
Enrollment | Post-allocation | Follow-up | ||||
Timepoint | Ambulance | During primary PCI | Following Primary PCI | During admission at Rigshospitalet | Days 90 | |
Enrolment: | ||||||
Eligibility screen | X | |||||
Informed consent | X | |||||
Randomization | X | |||||
Interventions: | ||||||
Infusion of study medicine | X | |||||
Assessments: | ||||||
CMR | X | X | ||||
Infarct sizea | X | X | ||||
Extent of MVOa | X | X | ||||
IMHa | X | |||||
AARa | X | |||||
MSIa | X | X | ||||
LVEFa | X | X | ||||
Mortality and hospitalization for heart failure | X | |||||
Biochemistry and biobank samples | X | X | X | |||
Coronary physiology | X |