StrokePre-HASTNCT04555499
A Diagnosis Study of a New Prehospital Strokeidentification Test, the PreHospitalt Ambulans Stroke Test (PreHAST), to be Used to Triage Patients With Suspected Stroke
An observational study of Stroke, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Standardized neurological examination
- How many people
- 78 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2014to Jan 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: Patients with suspected stroke using pre hospital services in region Skåne, Sweden or being admited to Södersjukhuset in Stockholm, Sweden
Who may be able to join
- Suspected stroke
Who cannot join
- Unconscious
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Pre hospital services in Skåne, Sweden
Hässleholm, Skåne County
Södersjukhuset
Stockholm
About this study
Official title: A Validation Study of a Structured Diagnostic Examination of Patients With Suspected or Confirmed Stroke Resulting in a Stroke Score
The aim of the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. The test is more extensive then the FAST or Cincinatti Stroke Scale and is in some aspects similar to the NIHSS but is shorter, easier and faster to perform to improve interexaminator variability and improve validity in less trained personal. The test is intended for awake patients with suspected stroke
Read the detailed description
PreHAST (PreHospital Ambulance Stroke Test)
- for suspected stroke in awake patients The following parameters are tested.
- Commands • Evaluates ability to understand verbal commands (impressive aphasia?) and to carry out complex commands (apraxia?)
- Give the command: open and close your eyes! Grip your hand! (non-paretic side) 0 - two correct 2 - one or none correct
- Eye position • Evaluates involuntary deviation of the gaze (déviation conjugée?). If present, this implies a serious injury and thus 2 p are given.
- Observ if the patient have the eyes trained to one direction unmotivated 0 - normal 2 - Patient gaze in one direction only or preferably
- Visual field
- The test should be conducte in both left and right visual field simulatneously to evaluate both if hemianopsia and/or negelct are present. Both symptoms implieas a sever injury and thus 2 p are given
- Look the patient in the eyes and wave in both visual fields simultaneously. Ask the patient to point at the hand or hands waving. 0 - normal 2 - Only distinguishes one hand
- Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging
- Arm paresis Is tested in lying or sitting position, one arm at the time. Start with the strongest arm. Lift the arm 45 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the arm, assist. If the inability to keep the arm elevated is due to pain - score 0 Right Left 0 - can maintain the arm in postition for 10 s 1 - The arm drifts down from the initial position within 10 s but does not rely on support 2 - Falls down to support within 10 s or directly
- Leg paresis Test in lying or sitting position, one leg at the time. Start with the strongest leg. Lift the leg 30 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the leg, assist. If the inability to keep the leg elevated is due to pain - score 0 Right Left 0 - can maintain the leg in position for 5 s 1 - The leg drifts down from the initial position within 5 s but does not rely on support 2 - Falls down to support within 5 s or directly
- Sensory (pain)
- Evaluation of eventual loss of sensory function. It is important that pain is tested as not to miss a serious and not too uncommon type of stroke localized in the brain stem (Wallenberg´s syndrome).
- Pinch the bend of the arms and legs, respectively. The stimuli shall be done simultaneously at the left and right side. Ask the patient if he/she can feel the stimuli in the same way on both sides. If the patient only registers stimuli on one side, 2 p are given. 0 - normal 1 - registers stimuli on both sides but less on one side 2 - Only registers the stimuli on one side
- Language • Evaluate if the patient has an understandable speech as stroke can cause both slurred speech (dysarthria) and affected ability to find words (aphasia). This test does not distinguish between dysarthria or dysphasia . Patient who does not speak at all (is mute) is given 2 p.
- Ability to talk is noted during the examination. If uncertain, ask the patient to repeat: "the weather is pretty today" 0 - Normal 1 -Slight or moderate dysartria or aphasia. Communication possible. 2 - Severe dysarthria or aphasia. Communication basically not possible.
- Conditions
- Stroke
- Being tested
- Standardized neurological examination
- Keywords
- stroke pre hospital identification TIA, Patients with suspected stroke, Ability to give informed consent
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized neurological examinationOther
| Study group | Role | What they receive |
|---|---|---|
| Suspected stroke | Patients with suspected stroke who are evaluated by paramedics Receives: Other: Standardized neurological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke diagnosis
The Pre-HAST is performed in the ambulance, in the emergency room or in the acute stroke ward. Final diagnosis of stroke and imaging data is matched to the findings in the Pre-HAST test
Measured: within 2 weeks of recrutiment
Secondary outcomes (1)
neuroimaging findings of large vessel oclusion
Imaging findings of examined patients are reviewed
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study startJan 2014
- Primary completionMay 2014
- Study completionJan 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 StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Mia von Euler, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555499
- Sponsor's protocol ID
- Pre-HAST
- Acronym
- Pre-HAST
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2014
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andsberg G, Esbjornsson M, Olofsson A, Lindgren A, Norrving B, von Euler M. PreHospital Ambulance Stroke Test - pilot study of a novel stroke test. Scand J Trauma Resusc Emerg Med. 2017 Apr 11;25(1):37. doi: 10.1186/s13049-017-0377-x.
PubMed 28399897
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of a Structured Diagnostic Examination of Patients With Suspected or Confirmed Stroke Resulting in a Stroke Score
- ClinicalTrials.gov ID
- NCT04555499
- Acronym / sponsor ID
- Pre-HAST / Pre-HAST
- Conditions
- Stroke
- Keywords
- stroke pre hospital identification TIA, Patients with suspected stroke, Ability to give informed consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jan 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 18 Sep 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 the Pre-HAST study is to improve identification and triage of patients with suspected stroke in order to get the right patient to the right level of care as fast as possible. Furthermore, the scale is also intended to use follow stroke symptoms in emergency care. The test is more extensive then the FAST or Cincinatti Stroke Scale and is in some aspects similar to the NIHSS but is shorter, easier and faster to perform to improve interexaminator variability and improve validity in less trained personal. The test is intended for awake patients with suspected stroke
Detailed description
PreHAST (PreHospital Ambulance Stroke Test)
- for suspected stroke in awake patients The following parameters are tested.
- Commands • Evaluates ability to understand verbal commands (impressive aphasia?) and to carry out complex commands (apraxia?)
- Give the command: open and close your eyes! Grip your hand! (non-paretic side) 0 - two correct 2 - one or none correct
- Eye position • Evaluates involuntary deviation of the gaze (déviation conjugée?). If present, this implies a serious injury and thus 2 p are given.
- Observ if the patient have the eyes trained to one direction unmotivated 0 - normal 2 - Patient gaze in one direction only or preferably
- Visual field
- The test should be conducte in both left and right visual field simulatneously to evaluate both if hemianopsia and/or negelct are present. Both symptoms implieas a sever injury and thus 2 p are given
- Look the patient in the eyes and wave in both visual fields simultaneously. Ask the patient to point at the hand or hands waving. 0 - normal 2 - Only distinguishes one hand
- Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging
- Arm paresis Is tested in lying or sitting position, one arm at the time. Start with the strongest arm. Lift the arm 45 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the arm, assist. If the inability to keep the arm elevated is due to pain - score 0 Right Left 0 - can maintain the arm in postition for 10 s 1 - The arm drifts down from the initial position within 10 s but does not rely on support 2 - Falls down to support within 10 s or directly
- Leg paresis Test in lying or sitting position, one leg at the time. Start with the strongest leg. Lift the leg 30 degrees and ask the patient to keep in the position for 10 s. Count audible. If the patient can't lift the leg, assist. If the inability to keep the leg elevated is due to pain - score 0 Right Left 0 - can maintain the leg in position for 5 s 1 - The leg drifts down from the initial position within 5 s but does not rely on support 2 - Falls down to support within 5 s or directly
- Sensory (pain)
- Evaluation of eventual loss of sensory function. It is important that pain is tested as not to miss a serious and not too uncommon type of stroke localized in the brain stem (Wallenberg´s syndrome).
- Pinch the bend of the arms and legs, respectively. The stimuli shall be done simultaneously at the left and right side. Ask the patient if he/she can feel the stimuli in the same way on both sides. If the patient only registers stimuli on one side, 2 p are given. 0 - normal 1 - registers stimuli on both sides but less on one side 2 - Only registers the stimuli on one side
- Language • Evaluate if the patient has an understandable speech as stroke can cause both slurred speech (dysarthria) and affected ability to find words (aphasia). This test does not distinguish between dysarthria or dysphasia . Patient who does not speak at all (is mute) is given 2 p.
- Ability to talk is noted during the examination. If uncertain, ask the patient to repeat: "the weather is pretty today" 0 - Normal 1 -Slight or moderate dysartria or aphasia. Communication possible. 2 - Severe dysarthria or aphasia. Communication basically not possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected stroke | – | Other: Standardized neurological examinationPatients with suspected stroke who are evaluated by paramedics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected stroke using pre hospital services in region Skåne, Sweden or being admited to Södersjukhuset in Stockholm, Sweden
Key inclusion criteria (1 listed)
- Suspected stroke
Key exclusion criteria (1 listed)
- Unconscious
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 |
|---|---|---|
| Standardized neurological examination | Other | Suspected stroke |
Primary outcome
stroke diagnosis
Time frame: within 2 weeks of recrutiment
The Pre-HAST is performed in the ambulance, in the emergency room or in the acute stroke ward. Final diagnosis of stroke and imaging data is matched to the findings in the Pre-HAST test
1 secondary outcome
neuroimaging findings of large vessel oclusion
Time frame: within 3 months
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 18 Sep 2020.
- Results publication: PubMed 28399897Andsberg G, Esbjornsson M, Olofsson A, Lindgren A, Norrving B, von Euler M. PreHospital Ambulance Stroke Test - pilot study of a novel stroke test. Scand J Trauma Resusc Emerg Med. 2017 Apr 11;25(1):37. doi: 10.1186/s13049-017-0377-x.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Karolinska Institutet at 2 sites in Sweden.
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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
stroke diagnosis (time frame: within 2 weeks of recrutiment). 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 NCT04555499, 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 18 Sep 2020.