Stroke, AcuteSTROKE-APPNCT06332989
Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting
An observational study of Stroke, Acute and Pre-hospital Triage, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Pre-hospital Triage, Stroke Treatment
- What is being tested?
- stroke-APP
- How many people
- 3,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2024to 1 Feb 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients for whom a stroke code was activated.
Who may be able to join
- patients for whom a stroke code is activated
Who cannot join
- < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University medical center
Leiden
Nyika D Kruyt, MD. PhD, 0031-715262139, n.d.kruyt@lumc.nl
About this study
Official title: Comparison of Prehospital Stroke Screening Scales in the Ambulance Setting; a Multiregional, Multicenter Observational Cohort Study
There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics
Read the detailed description
this is a multicenter multiregional cohort study including about 3000 stroke code patients. In all patients an application will be filled out before hospital arrival including items that enable us to reconstruct all previously published stroke scales.
Data from the application will be related to in hospital data of the same patient. In order to do this we will use a trusted third party for data coupling.
- Conditions
- Stroke, Acute, Pre-hospital Triage, Stroke Treatment, Stroke Code
- Being tested
- stroke-APP
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke-APPOther
Ambulane paramedics will use an online application to fill in several observations on scen
What is being measured
The primary outcome is the main question the study is designed to answer.
final diagnosis
Diangosis by treating physician
Measured: discharge or after 3 months
treated with reperfusion therapy
treatment with IV thrombolysis; endovascular therapy or surgery
Measured: first 24 hours after admission
additional investigations
CT scans performed
Measured: on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alrijne Ziekenhuis Leiderdorp, Groene Hart Ziekenhuis, Medical Center Haaglanden, HagaZiekenhuis, Reinier de Graaf Groep, Regionale Ambulance Voorziening Hollands Midden
- Responsible party
- Principal investigator, NyikaKruyt, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332989
- Sponsor's protocol ID
- N22.129
- Acronym
- STROKE-APP
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prehospital Stroke Screening Scales in the Ambulance Setting; a Multiregional, Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06332989
- Acronym / sponsor ID
- STROKE-APP / N22.129
- Conditions
- Stroke, Acute, Pre-hospital Triage, Stroke Treatment, Stroke Code
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Alrijne Ziekenhuis Leiderdorp, Groene Hart Ziekenhuis, Medical Center Haaglanden, HagaZiekenhuis, Reinier de Graaf Groep, Regionale Ambulance Voorziening Hollands Midden
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Mar 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.
There are everal scales designed to help ambulance paramedics to identify a patient with a stroke and activate a stroke code. These scales were never tested in the field in a large unselected patient sample. We aim to perform an in-the field head tot head comparison of all published stroke scales designed to be used by ambulance paramedics
Detailed description
this is a multicenter multiregional cohort study including about 3000 stroke code patients. In all patients an application will be filled out before hospital arrival including items that enable us to reconstruct all previously published stroke scales.
Data from the application will be related to in hospital data of the same patient. In order to do this we will use a trusted third party for data coupling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients for whom a stroke code was activated.
Key inclusion criteria (1 listed)
- patients for whom a stroke code is activated
Key exclusion criteria (1 listed)
- < 18 years
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 |
|---|---|---|
| stroke-APPAmbulane paramedics will use an online application to fill in several observations on scen | Other | – |
Primary outcome
final diagnosis
Time frame: discharge or after 3 months
Diangosis by treating physician
treated with reperfusion therapy
Time frame: first 24 hours after admission
treatment with IV thrombolysis; endovascular therapy or surgery
additional investigations
Time frame: on admission
CT scans performed
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 27 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Stroke, Acute and Pre-hospital Triage, run by Leiden University Medical Center at 1 site in Netherlands.
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: looking for participants now, as of the sponsor's last update on 27 Mar 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 Netherlands. 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?
final diagnosis (time frame: discharge or after 3 months). The study lists 3 primary outcomes in all. 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 Mar 2024.