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

NCT ID: NCT06731257

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2026-03-31

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

Conditions

Cardiovascular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

virtual ward early discharge

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Muzahir Tayebjee

Role: primary

Other Identifiers

CD24/163181

Identifier Type: -

Identifier Source: org_study_id