Clinical trial NCT02088346: Acute Stroke Advancing Program Using Telemedicine
Official title: Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke
Thrombolysis
Tissue plasminogen activator
Urokinase
Telemedicine
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Department of Science and Technology of Shanxi Province
name: Air Force Military Medical University, China
First posted: 2014-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients treated with intravenous thrombolysis
timeFrame: at 4.5 hours
Secondary outcomes:
measure: Favorite outcome at 3 months (modified Rankin score ≤2)
timeFrame: at 1 month/3 months
measure: Stroke complications
timeFrame: at 24 hours/7days
measure: Fatal and nonfatal cardiovascular events
timeFrame: at 7 days
measure: All cause mortality
timeFrame: at 3 months
measure: Time intervals
timeFrame: at 24 hours
measure: Length of hospitalization
timeFrame: at 3 months
Other outcomes:
Locations:
city: Yulin
country: China
facility: Xingyuan Hospital
state: Shanxi
city: Yulin
country: China
facility: Yulin First People's Hospital
state: Shanxi
city: Yulin
country: China
facility: Yulin Second People's Hospital
state: Shanxi
city: Yulin
country: China
facility: Yuyang District People's Hospital
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Zhirong Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
References:
citation: Yuan Z, Wang B, Li F, Wang J, Zhi J, Luo E, Liu Z, Zhao G. Intravenous thrombolysis guided by a telemedicine consultation system for acute ischaemic stroke patients in China: the protocol of a multicentre historically controlled study. BMJ Open. 2015 May 15;5(5):e006704. doi: 10.1136/bmjopen-2014-006704.