A Diagnosis Study of a New Prehospital Strokeidentification Test, the PreHospitalt Ambulans Stroke Test (PreHAST), to be Used to Triage Patients With Suspected Stroke (Pre-HAST)

September 14, 2020 updated by: Mia von Euler, Karolinska Institutet

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PreHAST (PreHospital Ambulance Stroke Test)

  • for suspected stroke in awake patients The following parameters are tested.

    1. 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

    2. 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

    3. 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

    4. Facial palsy Ask the patient to smile 0 - normal 1 - one side of the mouth is hanging

    5. 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

    6. 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

    7. 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

    8. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

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

  • Sweden
      • Stockholm, Sweden
        • Södersjukhuset
    • Skåne
      • Hässleholm, Skåne, Sweden
        • Pre hospital services in Skåne, Sweden

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected stroke using pre hospital services in region Skåne, Sweden or being admited to Södersjukhuset in Stockholm, Sweden

Description

Inclusion Criteria:

  • Suspected stroke

Exclusion Criteria:

  • Unconscious

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Suspected stroke
Patients with suspected stroke who are evaluated by paramedics
Other: Standardized neurological examination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 2 weeks of recrutiment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
neuroimaging findings of large vessel oclusion
Time Frame: within 3 months
Imaging findings of examined patients are reviewed
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pre-HAST

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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