Acute Stroke Advancing Program Using Telemedicine
ASAP-Tel
Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
1 other identifier
observational
300
1 country
4
Brief Summary
The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 25, 2015
September 1, 2014
1 year
February 27, 2014
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients treated with intravenous thrombolysis
at 4.5 hours
Secondary Outcomes (6)
Favorite outcome at 3 months (modified Rankin score ≤2)
at 1 month/3 months
Stroke complications
at 24 hours/7days
Fatal and nonfatal cardiovascular events
at 7 days
All cause mortality
at 3 months
Time intervals
at 24 hours
- +1 more secondary outcomes
Study Arms (2)
Teleconsultation
Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares
Historical control
Usual stroke care without the guidance from hub hospital
Interventions
Telemedicine consultation system based on portable hardwares
Eligibility Criteria
Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset
You may qualify if:
- 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
You may not qualify if:
- Time of symptom onset unclear
- Unlikely to complete study through 3-month follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Xingyuan Hospital
Yulin, Shanxi, 719000, China
Yulin First People's Hospital
Yulin, Shanxi, 719000, China
Yulin Second People's Hospital
Yulin, Shanxi, 719000, China
Yuyang District People's Hospital
Yulin, Shanxi, 719000, China
Related Publications (1)
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.
PMID: 25979867DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhirong Liu, MD
Xijing Hospital
- STUDY DIRECTOR
Gang Zhao, MD
Xijing Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2014
First Posted
March 14, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
June 25, 2015
Record last verified: 2014-09