Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial

Last updated: December 11, 2024
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

virtual ward early discharge

Clinical Study ID

NCT06731257
CD24/163181
  • Ages 18-99
  • All Genders

Study Summary

Observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following ST elevation myocardial infarction is safe. This has not been tested in a randomised controlled trial. In this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. The primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. If the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successful revascularisation following STEMI

  • Zwolle score <=3

  • No bystander disease awaiting inpatient intervention at the time of screening orconsent (so if they have had intervention to a bystander vessel before this theywould be eligible)

Exclusion

Exclusion Criteria:

  • Haemodynamic instability (Killip class >I)

  • Left ventricular ejection fraction <45%<40%

  • Sustained ventricular or atrial arrhythmias requiring intervention

  • No support at home or social or physical circumstances preventing early discharge

  • Unable to use home monitoring equipment

  • Unwilling to consent or follow instructions

  • Patients visiting from out of our catchment area

  • Out-of hospital cardiac arrest

  • Patients repatriated to their local hospital within 24 hours

  • New or worsening renal failure (i.e. creatinine >=1.5x baseline)

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: virtual ward early discharge
Phase:
Study Start date:
June 24, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Leeds Teaching Hospital NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

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