CardiovascularVALIANT-STEMINCT06731257
Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
A study testing virtual ward early discharge in people with Cardiovascular, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular
- What is being tested?
- virtual ward early discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Muzahir Tayebjee, 01132066051, muzahir.tayebjee@nhs.net
About this study
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
- Being tested
- virtual ward early discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual ward early dischargeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | 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 |
| study group | 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. Receives: Other: virtual ward early discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start24 Jun 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731257
- Sponsor's protocol ID
- CD24/163181
- Acronym
- VALIANT-STEMI
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Ward-Assisted Very earLy dIschArge of Low-rIsk STEMI patieNTs: the VALIANT-STEMI Trial
- ClinicalTrials.gov ID
- NCT06731257
- Acronym / sponsor ID
- VALIANT-STEMI / CD24/163181
- Conditions
- Cardiovascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –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 |
| study group | Other | Other: virtual ward early dischargePatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual ward early dischargePatients 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 | study group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual ward early discharge in people with Cardiovascular, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality or any rehospitalisation (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.