NCT02310282

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 28, 2016

Status Verified

December 1, 2015

Enrollment Period

2.2 years

First QC Date

December 1, 2014

Last Update Submit

October 27, 2016

Conditions

Keywords

TelemedicineEmergency medicineStrokeStroke syndromes

Outcome Measures

Primary Outcomes (1)

  • 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)

    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.

    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.

    within 3 days

Study Arms (1)

Telemedicine

In-hospital telemedicine by a stroke expert aiming to assess stroke severity using the Unassisted TeleStroke Scale.

Device: Telemedicine

Interventions

In-hospital telemedicine

Telemedicine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age \> 18 years
  • Suspicion of acute stroke with symptom onset \< 72 h before teleconsultation
  • NIHSS score \> 0
  • Informed consent
  • Patients for whom telestroke consultation would delay any diagnostic or therapeutic intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jacques De Keyser, MD PhD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 8, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 28, 2016

Record last verified: 2015-12

Locations