Acute Ischemic StrokeNCT04951518
VAN Assessment Tool in the Treatment of Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Washington Regional Medical Center at 1 site in United States.
Trial summary
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- VAN Stroke Scale
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 17 Mar 2022
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Anyone experiencing acute ischemic stroke symptoms
Who may be able to join
- Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac
Who cannot join
- Stroke patients who arrive directly to the hospital (without the use of EMS services)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Regional Medical Center
Fayetteville, Arkansas, 72703
About this study
Official title: VAN - Training of Emergency Medical Services to Improve Stroke Outcomes in Northwest Arkansas
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction
Read the detailed description
The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.
The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.
- Conditions
- Acute Ischemic Stroke
- Being tested
- VAN Stroke Scale
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAN Stroke ScaleOther
V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients
| Study group | Role | What they receive |
|---|---|---|
| Van Positive | Large Vessel Occlusion Positive Receives: Other: VAN Stroke Scale | |
| Van Negative | Large Vessel Occlusion Negative Receives: Other: VAN Stroke Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of VAN Assessment Tool
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction
Measured: 1 Year
Secondary outcomes (4)
Eligibility for Thrombolysis
To investigate effect of the VAN tool to predict persons eligible for thrombolysis
Measured: 1 Year
Eligibility for Thrombectomy
To investigate effect of the VAN tool to predict persons eligible for thrombectomy
Measured: 1 Year
Door to Intervention Time
To investigate the effect of prehospital notification of VAN positive status vs routine notification on time door to needle or door to thrombectomy time
Measured: 1 Year
Modified Rankin Score
To compare the discharge disposition and Rankin score of patients post intervention with VAN prenotification vs routine notification. Rankin scores ranging from 0 - 5, with 0 being fully functioning and independent, and 5 being severe disability requiring constant nursing care.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start22 Oct 2020
- Primary completion31 Dec 2021
- Study completion17 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Washington Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951518
- Sponsor's protocol ID
- V-109
- Status last verified
- Apr 2022
- First submitted
- 28 Jun 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAN - Training of Emergency Medical Services to Improve Stroke Outcomes in Northwest Arkansas
- ClinicalTrials.gov ID
- NCT04951518
- Acronym / sponsor ID
- V-109
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Washington Regional Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 17 Mar 2022 (actual)
- First posted
- 6 Jul 2021 (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.
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction
Detailed description
The investigators propose to perform a 6-month pilot study in Northwest Arkansas in collaboration of two EMS providers; Central EMS and AirEvac. These local providers operate in the WRMC catchment area and transport over 90% of patients with a suspected stroke to WRMC comprehensive stroke center. Thus no changes to their standard operations would be implemented. The aim of this pilot study would be to test the accuracy of VAN-screening in the area in patients treated at WRMC - thus only patients who are brought to WRMC as per current protocol would be included in the study.
The investigators would train Central EMS and AirEvac personnel to perform the V.A.N screen, over a 2-month period (estimated June-July 2020) in several sessions at the Central EMS training center at 800 S. School Ave. in Fayetteville. This training would be performed by study investigators, assisted by medical students, residents, and advanced practice nurses (APNs). The training would consist of a training video, hands-on instruction, and sample scenarios.The investigators would survey all training participants to gather feedback on the format, delivery, and understanding of the training material. The PowerPoint presentation planned for the training session, as well as the post-training quiz, are attached as Appendices to this application. The investigators would expect a rate of 80% correct answers in the post-training quiz. All questions and scenarios would be discussed with all trainees after the quiz, and re-takes would be allowed.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Van Positive | – | Other: VAN Stroke ScaleLarge Vessel Occlusion Positive |
| Van Negative | – | Other: VAN Stroke ScaleLarge Vessel Occlusion Negative |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone experiencing acute ischemic stroke symptoms
Key inclusion criteria (1 listed)
- Patients treated for stroke at WRMC who are transported to the hospital by Central EMS or AirEvac
Key exclusion criteria (1 listed)
- Stroke patients who arrive directly to the hospital (without the use of EMS services)
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 |
|---|---|---|
| VAN Stroke ScaleV.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients | Other | Van Negative, Van Positive |
Primary outcome
Reliability of VAN Assessment Tool
Time frame: 1 Year
To investigate the reliability of VAN tool as administered by Emergency Medical Services personnel to predict presence of a large vessel occlusion in setting of cerebral ischemic infarction
4 secondary outcomes
Eligibility for Thrombolysis
Time frame: 1 Year
Eligibility for Thrombectomy
Time frame: 1 Year
Door to Intervention Time
Time frame: 1 Year
Modified Rankin Score
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Washington Regional Medical Center at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of VAN Assessment Tool (time frame: 1 Year). 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 27 Apr 2022.