Frederiksberg Hospital

• At a single Danish centre, 2,840 consecutive acute myocardial infarction patients were assessed over 13 March 2022 to 30 June 2025; 243 (8.6%) met the ORBI risk-score threshold and 100 were randomised.
• Of 243 eligible at-risk patients, 143 were not enrolled, most commonly because cardiogenic shock developed in the catheterisation laboratory before randomisation (62 patients).
• Recruitment was continuous without a temporary halt from first to last enrolment.
• CMR completion was 73–88% at ≤48 hours and 63–76% at 3 months, reflecting the clinical status of this at-risk population.
• The single-centre design and strict inclusion criteria may limit generalisability.

These findings describe the trial, not the service provider’s performance or responsibility.

• Recruitment ran from 3 May 2024 to 19 May 2025, with 134 patients screened and 67 randomised.
• The trial was conducted at a single Danish emergency department by clinicians experienced in regional anaesthesia, which may limit generalisability to other settings.
• The control-group block-success rate was 90%, below the 95% assumed for sample-size calculation, and the modest sample size produced uncertainty in the lidocaine versus ropivacaine 0.5% noninferiority comparison.

These findings describe the trial, not the service provider’s performance or responsibility.

• Few tumors had intermediate tumor mutational burden, making patient inclusion challenging.
• Nationwide collaboration allowing enrollment based on local tumor mutational burden testing supported inclusion despite low enrollment rates.
• Central whole-genome sequencing reclassified 2 locally intermediate-TMB patients as TMB-high and 4 as TMB-low, demonstrating eligibility-classification variability with local testing.
• Only 7 paired on-treatment biopsies were available, limiting translational endpoint assessment.

These findings describe the trial, not the service provider’s performance or responsibility.