Acute Stroke Advancing Program Using Telemedicine

Study Overview
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Brief Summary
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The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.

Detailed Description
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The rate of intravenous thrombolysis with tissue-type plasminogen activator or urokinase for stroke patients was extremely low in China. It has been demonstrated that telestroke may help to increase the rate of intravenous thrombolysis and improve the stroke care quality in the local hospitals. The aim of this study is to evaluate the effectiveness and safety of decision making of intravenous thrombolysis via telemedicine consultation system for acute ischemic stroke patients in China This trial network consists of one hub hospital (Xijing Hospital) and 14 spoke hospitals in the remote area of Shanxi Province. The telemedicine consultation system is an interactive, 2-way, wireless, audiovisual system based on portable hardwares--tablet computer or smartphone. Before this study, we have been investigating the usual stroke care quality in the spoke hospitals without the guidance from the hub hospital, which will be used as the historical control of this study. After that, the teleconsultation system will be introduced.

Official Title
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Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China

Conditions
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Stroke

Intervention / Treatment
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* Other: Telemedicine consultation system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years and less than 80 years Acute ischemic stroke Presenting to Emergency Department of spoke hospitals within 4.5 hours of stroke symptom onset National Institutes of Health Stroke Scale (NIHSS) between 4 and 25 Signed consent form by the patient or his relatives Exclusion Criteria: Time of symptom onset unclear Unlikely to complete study through 3-month follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teleconsultation<br>Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares | Other: Telemedicine consultation system<br>* Telemedicine consultation system based on portable hardwares<br>|
| Historical control<br>Usual stroke care without the guidance from hub hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients treated with intravenous thrombolysis |  | at 4.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorite outcome at 3 months (modified Rankin score ≤2) |  | at 1 month/3 months | 
| Stroke complications | They include symptomatic intracranial hemorrhage (sICH), symptomatic cerebral edema from an original brain infarction, cerebral hernia, seizure, severe extracranial bleeding, pulmonary embolism, pulmonary edema, deep venous thrombosis, and sepsis. | at 24 hours/7days | 
| Fatal and nonfatal cardiovascular events | They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure | at 7 days | 
| All cause mortality |  | at 3 months | 
| Time intervals | Those from stroke onset to arriving in emergency department(ED), and from arriving in ED to physician/CT initiation/CT interpretation/specific treatment. | at 24 hours | 
| Length of hospitalization |  | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Thrombolysis, Tissue plasminogen activator, Urokinase, Telemedicine