Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- 30-day all-cause mortality or any rehospitalisation
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Successful revascularisation following STEMI
- •Zwolle score \<=3
- •No bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible)
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)
Outcomes
Primary Outcomes
30-day all-cause mortality or any rehospitalisation
Time Frame: 24-48 hours
(time starts at admission of patient). No randomised controlled trials (RCTs) have compared 24-48 hours discharge to \>48 hours discharge in low-risk STEMI patients. To the knowledge there has been a prior meta-analysis included 5 RCTs comparing discharge at 48 to 72 hours versus \>72 hours and this was found to be safe(4). The 30-day event rate of any hospitalisation or all-cause death that was available from 3 RCTs was 31/489 (6.3%) in the routine care arm and 21/515 (4.1%) in the early discharge arm. For a non-inferiority design, assuming an event rate of 6% in the routine care arm and 4% in the very early discharge arm and a non-inferiority margin of 2.5%, 290 patients would be needed in each arm to provide 80% power, at 5% significance level. To allow for approximate 3-4% drop-out rate, it is intended to recruit 600 patients in total