Stroke SyndromeHOGANNCT03009656
Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?
An observational study of Stroke Syndrome and Stroke Hemorrhagic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Syndrome, Stroke Hemorrhagic, Stroke, Acute
- What is being tested?
- No study specific interventions
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2017to 31 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: Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.
Who may be able to join
- Age ≥ 18 years.
- Non-refusal of "general consent"
- Patients with focal clinical neurological deficits with symptom onset of < 6 hours or wake-up strokes.
Who cannot join
- Interval from symptom onset to clinical examination of > 6 hours.
- Patients who do not have focal clinical neurological deficit at examination will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Christoph Schankin, PD Dr. med. contact
Switzerland1 site, 1 recruiting
- Recruiting
Bern University Hospital - Inselspital
Bern, Canton of Bern, 3010
Christoph Schankin, PD Dr. med.
About this study
The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.
Read the detailed description
Background:
The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate with poor outcome. These studies showed that there is a correlation of clinical symptoms with the mechanism of stroke, which is important for the outcome after treatment. Importantly, however, the quality of clinical assessment itself is likely highly variable, for example depending on the experience of the treating physician. Factors influencing this clinical assessment, which needs to be done under high temporal and emotional pressure in the emergency setting have not been investigated so far but might be crucial for rapid and successful treatment ("time is brain").In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.
Rationale:
By assessing whether prediction of aetiology of acute neurological deficits is experience-based the investigators aim to understand what symptoms/signs impede the in-experienced from swiftly making the correct diagnosis in the emergency setting. This should help to improve resident training and with this treatment of patients with acute neurological deficits.
- Conditions
- Stroke Syndrome, Stroke Hemorrhagic, Stroke, Acute, Strokes Thrombotic, Emergencies, Diagnostic Self Evaluation
- Being tested
- No study specific interventions
- Keywords
- Stroke, Emergency, Focal Neurological Deficits, Diagnostic
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Thrombotic Stroke, Emergencies, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study specific interventionsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits
Primary endpoint is the proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits, calculated by comparing the initial assessment with the final diagnosis at discharge. If the initial assessment was correct, the diagnosis of the emergency physician will be rated as correct (correct answer = Ac), if it was incorrect, it will be rated as incorrect (incorrect answer = Ai).
The proportion of accurate initial diagnoses will be calculated as:
Ac / (Ac + Ai)
Measured: 7 days +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start10 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SyndromeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Schankin, PD Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009656
- Sponsor's protocol ID
- 2016-01819
- Other IDs
- 2016
- Acronym
- HOGAN
- Status last verified
- Jul 2019
- First submitted
- 2 Jan 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?
- ClinicalTrials.gov ID
- NCT03009656
- Acronym / sponsor ID
- HOGAN / 2016-01819
- Conditions
- Stroke Syndrome, Stroke Hemorrhagic, Stroke, Acute, Strokes Thrombotic, Emergencies, Diagnostic Self Evaluation
- Keywords
- Stroke, Emergency, Focal Neurological Deficits, Diagnostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- 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 emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.
Detailed description
Background:
The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate with poor outcome. These studies showed that there is a correlation of clinical symptoms with the mechanism of stroke, which is important for the outcome after treatment. Importantly, however, the quality of clinical assessment itself is likely highly variable, for example depending on the experience of the treating physician. Factors influencing this clinical assessment, which needs to be done under high temporal and emotional pressure in the emergency setting have not been investigated so far but might be crucial for rapid and successful treatment ("time is brain").In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.
Rationale:
By assessing whether prediction of aetiology of acute neurological deficits is experience-based the investigators aim to understand what symptoms/signs impede the in-experienced from swiftly making the correct diagnosis in the emergency setting. This should help to improve resident training and with this treatment of patients with acute neurological deficits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Non-refusal of "general consent"
- Patients with focal clinical neurological deficits with symptom onset of < 6 hours or wake-up strokes.
Key exclusion criteria (2 listed)
- Interval from symptom onset to clinical examination of > 6 hours.
- Patients who do not have focal clinical neurological deficit at examination will not be included in the study.
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 |
|---|---|---|
| No study specific interventions | Other | – |
Primary outcome
Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits
Time frame: 7 days +/- 7 days
Primary endpoint is the proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits, calculated by comparing the initial assessment with the final diagnosis at discharge. If the initial assessment was correct, the diagnosis of the emergency physician will be rated as correct (correct answer = Ac), if it was incorrect, it will be rated as incorrect (incorrect answer = Ai). The proportion of accurate initial diagnoses will be calculated as: Ac / (Ac + Ai)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke Syndrome
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Christoph Schankin, PD Dr. med. contact
Christoph Schankin, PD Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
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 Syndrome and Stroke Hemorrhagic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph Schankin, PD Dr. med. (christoph.schankin@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits (time frame: 7 days +/- 7 days). 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 8 Jul 2019.