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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular
• Intervention / Treatment: Other: virtual ward early discharge

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Leeds Teaching Hospital NHS Trust
    • Contact: Muzahir Tayebjee; Phone Number: 01132066051; Email: muzahir.tayebjee@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; For the standard group and study participants the clinical records will be reviewed to check if any primary or secondary endpoints were met. They will be contacted at 30 days for a telephone consultation after the index event (time from when patient was admitted), and they will be asked to fill in a patient satisfaction questionnaire
Other: study group; Patients who are randomised to the study group will receive a blood pressure monitor and instructions on how to use the device and transfer data to the study team. The study nurses will contact the patient every day for 3 days following their discharge and perform an virtual ward round assessment by telephone (see table). This will determine whether the patient continues to be monitored via the virtual ward, or whether they need to be referred to the clinical team. They will be issued with an emergency contact number out of hours (coronary care unit LGI) and the nursing hub will operate from 8am to 5pm 7 days a week. They will be referred to the community cardiac rehabilitation service whilst on the pathway.	Other: virtual ward early discharge; Patients who are randomised to the study group will receive a blood pressure monitor and instructions on how to use the device and transfer data to the study team. The study nurses will contact the patient every day for 3 days following their discharge and perform an virtual ward round assessment by telephone (see table). This will determine whether the patient continues to be monitored via the virtual ward, or whether they need to be referred to the clinical team. They will be issued with an emergency contact number out of hours (coronary care unit LGI) and the nursing hub will operate from 8am to 5pm 7 days a week. They will be referred to the community cardiac rehabilitation service whilst on the pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day all-cause mortality or any rehospitalisation	(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	24-48 hours

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CD24/163181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No