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

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

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Key information

Conditions

Cardiovascular

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

Location status: Recruiting

Location contact

Muzahir Tayebjee

CONTACT

[email protected]

01132066051

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

virtual ward early discharge

Other

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.

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

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Acronym: VALIANT-STEMI

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Dec 12, 2024
Registry last updated: Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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