Acute Stroke Advancing Program Using Telemedicine

• Conditions: Stroke
• Interventions: Other: Telemedicine consultation system

• Registration Number: NCT02088346
• Lead Sponsor: Xijing Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-25
• Primary Completion: 2015-08
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Teleconsultation	Telemedicine consultation system	Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares

Primary Outcome Measures

Name	Time	Method
Percentage of patients treated with intravenous thrombolysis	at 4.5 hours

Secondary Outcome Measures

Name	Time	Method
Fatal and nonfatal cardiovascular events	at 7 days	They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure
All cause mortality	at 3 months
Favorite outcome at 3 months (modified Rankin score ≤2)	at 1 month/3 months
Time intervals	at 24 hours	Those from stroke onset to arriving in emergency department(ED), and from arriving in ED to physician/CT initiation/CT interpretation/specific treatment.
Stroke complications	at 24 hours/7days	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.
Length of hospitalization	at 3 months

Trial Locations

Locations (4)

Yulin Second People's Hospital; 🇨🇳 Yulin, Shanxi, China

Xingyuan Hospital; 🇨🇳 Yulin, Shanxi, China

Yulin First People's Hospital; 🇨🇳 Yulin, Shanxi, China

Yuyang District People's Hospital; 🇨🇳 Yulin, Shanxi, China