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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
United Kingdom
Leeds Teaching Hospital NHS Trust
RECRUITING
Leeds
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2026-03
Participants
Target number of participants: 600
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: The Leeds Teaching Hospitals NHS Trust

This content was sourced from clinicaltrials.gov