Acute Stroke Advancing Program Using Telemedicine

Stroke Clinical Trial

— ASAP-Tel  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02088346
• Other study ID #: Xijing-Tele-001
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2014
• Last updated: June 23, 2015
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: September 2014
• Source: Xijing Hospital
• Contact: Ziwen Yuan, MD
• Email: yuan0929rong[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Telemedicine consultation system
Telemedicine consultation system based on portable hardwares

Locations

Country	Name	City	State
China	Xingyuan Hospital	Yulin	Shanxi
China	Yulin First People's Hospital	Yulin	Shanxi
China	Yulin Second People's Hospital	Yulin	Shanxi
China	Yuyang District People's Hospital	Yulin	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Xijing Hospital	Department of Science and Technology of Shanxi Province, Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients treated with intravenous thrombolysis		at 4.5 hours	No
Secondary	Favorite outcome at 3 months (modified Rankin score =2)		at 1 month/3 months	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	All cause mortality		at 3 months	Yes
Secondary	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	No
Secondary	Length of hospitalization		at 3 months	No