Acute Stroke Advancing Program Using Telemedicine

N/AUnknownNCT02088346

Xijing Hospital300 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Stroke

Interventions

Telemedicine consultation systemOTHER

Telemedicine consultation system based on portable hardwares

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Xingyuan Hospital

Yulin, Shanxi, China

RECRUITING

Yulin First People's Hospital

Yulin, Shanxi, China

NOT_YET_RECRUITING

Yulin Second People's Hospital

Yulin, Shanxi, China

RECRUITING

Outcomes

Primary Outcomes

Percentage of patients treated with intravenous thrombolysis

Time frame: at 4.5 hours

Secondary Outcomes

Favorite outcome at 3 months (modified Rankin score ≤2)

Time frame: 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.

Time frame: 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

Time frame: at 7 days

All cause mortality

Time frame: 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.

Time frame: at 24 hours

Length of hospitalization

Time frame: at 3 months

Central Contacts

Ziwen Yuan, MD

CONTACT

yuan0929rong@hotmail.com

Zhirong Liu, MD

CONTACT

liuzhir@fmmu.edu.cn

Data from ClinicalTrials.gov

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