Acute Stroke Advancing Program Using Telemedicine

NCT ID: NCT02088346

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Teleconsultation

Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares

Telemedicine consultation system

Intervention Type OTHER

Telemedicine consultation system based on portable hardwares

Historical control

Usual stroke care without the guidance from hub hospital

No interventions assigned to this group

Interventions

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Telemedicine consultation system

Telemedicine consultation system based on portable hardwares

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Science and Technology of Shanxi Province

UNKNOWN

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhirong Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Gang Zhao, MD

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

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Xingyuan Hospital

Yulin, Shanxi, China

Site Status RECRUITING

Yulin First People's Hospital

Yulin, Shanxi, China

Site Status NOT_YET_RECRUITING

Yulin Second People's Hospital

Yulin, Shanxi, China

Site Status RECRUITING

Yuyang District People's Hospital

Yulin, Shanxi, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Ziwen Yuan, MD

Role: CONTACT

Zhirong Liu, MD

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 25979867 (View on PubMed)

Other Identifiers

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Xijing-Tele-001

Identifier Type: -

Identifier Source: org_study_id

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