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

Stroke Clinical Trial

— TeleCLASS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02310282
• Other study ID #: B.U.N. 143201010021
• Status: Active, not recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: October 27, 2016
• Start date: November 2014
• Est. completion date: January 2017

Study information

• Verified date: December 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Telemedicine
In-hospital telemedicine

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	within 3 days	No
Secondary	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)	within 3 days	No