Acute StrokeNCT04404504
Smartphone-App Based Prediction of Large Vessel Occlusion
An observational study of Acute Stroke, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 20 Mar 2019to 30 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with suspected acute stroke that are transferred by the Essen emergency service to the university hospital Essen shall be recruited
All patients above the age of 18 with suspected acute stroke transferred to the university hospital Essen.
Inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted FAST-ED by EMS prior to admission.
Exclusion criteria: Known symptom onset beyond 24 Hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone-App Based Prediction of Large Vessel Occlusion in Suspected Stroke by Emergency Medical Service Using FAST-ED
The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).
Read the detailed description
The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.
- Conditions
- Acute Stroke
- Keywords
- Prehospital Triage
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of large vessel occlusion
Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start20 Mar 2019
- Primary completion1 Aug 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Köhrmann, University Hospital, Essen
- Investigators
- Martin Köhrmann, Prof. Dr., Study director, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404504
- Sponsor's protocol ID
- 18-8162
- Status last verified
- Aug 2022
- First submitted
- 18 May 2020
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frank B, Lembeck T, Toppe N, Brune B, Bozkurt B, Deuschl C, Nogueira RG, Dudda M, Risse J, Kill C, Forsting M, Kleinschnitz C, Kohrmann M. FAST-ED scale smartphone app-based prediction of large vessel occlusion in suspected stroke by emergency medical service. Ther Adv Neurol Disord. 2021 Nov 14;14:17562864211054962. doi: 10.1177/17562864211054962. eCollection 2021.
PubMed 34804205
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-App Based Prediction of Large Vessel Occlusion in Suspected Stroke by Emergency Medical Service Using FAST-ED
- ClinicalTrials.gov ID
- NCT04404504
- Acronym / sponsor ID
- 18-8162
- Conditions
- Acute Stroke
- Keywords
- Prehospital Triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 May 2020 (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.
The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).
Detailed description
The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.
Study design
- Observational model
- Other
- 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 adult patients with suspected acute stroke that are transferred by the Essen emergency service to the university hospital Essen shall be recruited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of large vessel occlusion
Time frame: Baseline
Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A)
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 1 Sep 2022.
- Results publication: PubMed 34804205Frank B, Lembeck T, Toppe N, Brune B, Bozkurt B, Deuschl C, Nogueira RG, Dudda M, Risse J, Kill C, Forsting M, Kleinschnitz C, Kohrmann M. FAST-ED scale smartphone app-based prediction of large vessel occlusion in suspected stroke by emergency medical service. Ther Adv Neurol Disord. 2021 Nov 14;14:17562864211054962. doi: 10.1177/17562864211054962. eCollection 2021.
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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.
Martin Köhrmann, Prof. Dr. study director
University Hospital, Essen
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 Stroke, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Sep 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 Germany. 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?
Presence of large vessel occlusion (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404504, which also lists 1 linked publication.
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 1 Sep 2022.