Stroke
Conditions
Keywords
Stroke, Thrombolysis, Tissue plasminogen activator, Urokinase, Telemedicine
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.
Interventions
OTHERTelemedicine consultation system
Telemedicine consultation system based on portable hardwares
Sponsors
Department of Science and Technology of Shanxi Province
Air Force Military Medical University, China
Xijing Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients treated with intravenous thrombolysis | at 4.5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| Length of hospitalization | at 3 months | — |
| All cause mortality | at 3 months | — |
Countries
China
Contacts
Primary ContactZiwen Yuan, MD
Backup ContactZhirong Liu, MD
Outcome results
None listed