Acute cardiac care & resuscitation
Early support in patients with St-segment elevation myocardial infarction complicated by shock. Design of exception from informed consent processes in recover iv trial
Study context
- Population
- Patients with acute MI-related cardiogenic shock (AMI-CS)
- Comparison
- Early microaxial flow pump vs no early mechanical circulatory support (MCS)
Methodological detailsRECOVER IV, multicentre, US and Europe, exception from informed consent, tiered consent process, central IRB, Protocol approved by a central IRB with a tiered consent process and exception from informed consent (EFIC) procedures, Standardized community consultation and public disclosure developed and implemented centrally by an Emergency Care Core
- RECOVER IV
- Multicentre
- US and Europe
- Exception from informed consent
- Tiered consent process
- Central IRB
- Protocol approved by a central IRB with a tiered consent process and EFIC procedures
- Standardized community consultation and public disclosure developed and implemented centrally by an Emergency Care Core
Primary result
As reported in the abstract
EFIC process and methods used to implement an AMI-CS trial in the US
- Central IRB approved the protocol with a tiered consent process and EFIC procedures
- Standardised community consultation and public disclosure activities developed and implemented centrally by an Emergency Care Core
Original publication
Early support in patients with St-segment elevation myocardial infarction complicated by shock. Design of exception from informed consent processes in recover iv trial. Am Heart J. Published 2 July 2025. doi:10.
Summarised from the published abstract; every number is checked against it