Telemedicine for Optimized Collection of CLinical datA in Patients With Suspicion of Acute Stroke (TeleCLASS)

October 27, 2016 updated by: Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

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

  • Belgium
      • Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with suspicion of acute stroke admitted to the Emergency Department or the Stroke Unit of the Universitair Ziekenhuis Brussel

Description

Inclusion criteria:

  • Age > 18 years
  • Suspicion of acute stroke with symptom onset < 72 h before teleconsultation
  • NIHSS score > 0
  • Informed consent

Exclusion criterion:

  • Patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Telemedicine
In-hospital telemedicine by a stroke expert aiming to assess stroke severity using the Unassisted TeleStroke Scale.
Device: Telemedicine
In-hospital telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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)
within 3 days

Collaborators and Investigators

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

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Study Chair: Jacques De Keyser, MD PhD, Universitair Ziekenhuis Brussel

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

November 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.U.N. 143201010021

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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