- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404504
Smartphone-App Based Prediction of Large Vessel Occlusion
August 29, 2022 updated by: Martin Köhrmann, University Hospital, Essen
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).
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
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Essen, NRW, Germany, 45147
- University Hospital, Essen
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of large vessel occlusion
Time Frame: Baseline
|
Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Martin Köhrmann, Prof. Dr., University Hospital, Essen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2019
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
May 18, 2020
First Submitted That Met QC Criteria
May 21, 2020
First Posted (Actual)
May 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 29, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-8162
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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