OASIS-AMICS Version 3.0 dated 27 Mar 2026
Research type
Research Study
Full title
Observational Assessment of Support with Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
IRAS ID
367390
Contact name
Poornima Sood
Contact email
Sponsor organisation
ABIOMED, Inc.
Clinicaltrials.gov Identifier
NCT06964685, ClinicalTrials.gov
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
What will happen:
Doctors will collect routine clinical information from the time the patient arrives for treatment, during the heart procedure (PCI), while the Impella is in place, at hospital discharge and at follow‑up visits at 30 days, 6 months and 1 year. Data include symptoms, vital signs, blood tests, procedures, device details, complications and hospital stays. No extra invasive tests are required beyond standard care.Main aim:
To describe safety and outcomes associated with Impella use in this emergency setting. The main measure is a combined in‑hospital safety outcome: major bleeding, severe loss of blood flow to a limb, or kidney failure requiring dialysis. Other outcomes include death, heart events and hospital readmissions up to one year.Who can take part:
Adults with acute heart attack and cardiogenic shock who receive an Impella device, with specific clinical inclusion and exclusion criteria set out in the protocol.Risks and benefits:
Since this is an observational study, there are no medical risks associated with participating. There may be no direct benefit to participants, but the information gathered could help improve how the device is used and patient care in the future.REC name
Wales REC 1
REC reference
26/WA/0161
Date of REC Opinion
8 Jun 2026
REC opinion
Favourable Opinion