StrokeTeleCLASSNCT02310282
Telemedicine for Optimized Collection of CLinical datA in Patients With Suspicion of Acute Stroke
An observational study of Stroke, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Observational prospective single-center study on the discriminatory value of the Unassisted TeleStroke Scale for differentiation between patients with lacunar stroke and those with other acute stroke syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telemedicine
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2014to Jan 2017
- 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 suspicion of acute stroke admitted to the Emergency Department or the Stroke Unit of the Universitair Ziekenhuis Brussel
Who may be able to join
- Age > 18 years
- Suspicion of acute stroke with symptom onset < 72 h before teleconsultation
- NIHSS score > 0
- Informed consent
Who cannot join
- Patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
About this study
Observational prospective single-center study on the discriminatory value of the Unassisted TeleStroke Scale for differentiation between patients with lacunar stroke and those with other acute stroke syndromes.
Read the detailed description
Assessment of stroke severity and differentiation between large-artery and small-artery stroke is pivotal for adequate treatment decision taking. Patients with small vessel stroke tend have a better prognosis than those with large artery disease. Further, patients with small artery infarction (lacunar stroke) have shown to respond well to treatment with intravenous recombinant tissue plasminogen activator (IV rt-PA), but are poor candidates for endovascular recanalization. Conversely, IV rt-PA may be less effective at restoring perfusion of large artery occlusion, a stroke subtype that may benefit from intra-arterial thrombolysis or embolectomy. Similarly, patients with large intracerebral hemorrhage or cerebellar hemorrhage may require neurosurgical interventions, such as intracranial pressure monitoring, ventricular drainage, surgical evacuation, or hemicraniectomy.
The purpose of TeleCLASS is to evaluate the discriminatory value of the Unassisted TeleStroke Scale (UTSS) obtained through in-hospital telemedicine for differentiation between patients with lacunar stroke and those with other acute stroke syndromes (nonLACS).
- Conditions
- Stroke
- Being tested
- Telemedicine
- Keywords
- Telemedicine, Emergency medicine, Stroke, Stroke syndromes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineDevice
In-hospital telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | In-hospital telemedicine by a stroke expert aiming to assess stroke severity using the Unassisted TeleStroke Scale. Receives: Device: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive validity of the UTSS for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Receiver operating curves, c-statistics, optimal thresholds, likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between lacunar syndrome (LACS) and other stroke syndromes (nonLACS)
Measured: within 3 days
Secondary outcomes (2)
Predictive validity of the UTSS for vessel status, classifying patients with acute ischemic stroke between those with large-artery occlusion and those without large-artery occlusion on imaging.
Receiver operating curves, c-statistics, optimal thresholds, likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between patients with large-artery occlusion and those without large-artery occlusion on imaging.
Measured: within 3 days
Predictive validity of the total UTSS score with cutoff value 6 for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between lacunar syndrome (LACS) and other stroke syndromes (nonLACS)
Measured: within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques De Keyser, MD PhD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310282
- Sponsor's protocol ID
- B.U.N. 143201010021
- Acronym
- TeleCLASS
- Status last verified
- Dec 2015
- First submitted
- 1 Dec 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Optimized Collection of CLinical datA in Patients With Suspicion of Acute Stroke
- ClinicalTrials.gov ID
- NCT02310282
- Acronym / sponsor ID
- TeleCLASS / B.U.N. 143201010021
- Conditions
- Stroke
- Keywords
- Telemedicine, Emergency medicine, Stroke, Stroke syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 8 Dec 2014 (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.
Observational prospective single-center study on the discriminatory value of the Unassisted TeleStroke Scale for differentiation between patients with lacunar stroke and those with other acute stroke syndromes.
Detailed description
Assessment of stroke severity and differentiation between large-artery and small-artery stroke is pivotal for adequate treatment decision taking. Patients with small vessel stroke tend have a better prognosis than those with large artery disease. Further, patients with small artery infarction (lacunar stroke) have shown to respond well to treatment with intravenous recombinant tissue plasminogen activator (IV rt-PA), but are poor candidates for endovascular recanalization. Conversely, IV rt-PA may be less effective at restoring perfusion of large artery occlusion, a stroke subtype that may benefit from intra-arterial thrombolysis or embolectomy. Similarly, patients with large intracerebral hemorrhage or cerebellar hemorrhage may require neurosurgical interventions, such as intracranial pressure monitoring, ventricular drainage, surgical evacuation, or hemicraniectomy.
The purpose of TeleCLASS is to evaluate the discriminatory value of the Unassisted TeleStroke Scale (UTSS) obtained through in-hospital telemedicine for differentiation between patients with lacunar stroke and those with other acute stroke syndromes (nonLACS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | – | Device: TelemedicineIn-hospital telemedicine by a stroke expert aiming to assess stroke severity using the Unassisted TeleStroke Scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of acute stroke admitted to the Emergency Department or the Stroke Unit of the Universitair Ziekenhuis Brussel
Key inclusion criteria (4 listed)
- Age > 18 years
- Suspicion of acute stroke with symptom onset < 72 h before teleconsultation
- NIHSS score > 0
- Informed consent
Key exclusion criteria (1 listed)
- Patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention
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 |
|---|---|---|
| TelemedicineIn-hospital telemedicine | Device | Telemedicine |
Primary outcome
Predictive validity of the UTSS for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Time frame: within 3 days
Receiver operating curves, c-statistics, optimal thresholds, likelihood ratios and accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value and overall accuracy) will be calculated to evaluate the predictive ability of the UTSS for discrimination between lacunar syndrome (LACS) and other stroke syndromes (nonLACS)
2 secondary outcomes
Predictive validity of the UTSS for vessel status, classifying patients with acute ischemic stroke between those with large-artery occlusion and those without large-artery occlusion on imaging.
Time frame: within 3 days
Predictive validity of the total UTSS score with cutoff value 6 for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification.
Time frame: within 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Jacques De Keyser, MD PhD study chair
Universitair Ziekenhuis Brussel
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, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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 Belgium. 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?
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?
Predictive validity of the UTSS for patient classification between lacunar syndromes and other stroke syndromes based on the Oxfordshire Community Stroke Project classification. (time frame: within 3 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 28 Oct 2016.