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Acute Stroke Advancing Program Using Telemedicine (ASAP-Tel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088346
Recruitment Status : Unknown
Verified September 2014 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2014
Last Update Posted : June 25, 2015
Sponsor:
Collaborators:
Department of Science and Technology of Shanxi Province
Air Force Military Medical University, China
Information provided by (Responsible Party):
Xijing Hospital

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

Condition or disease Intervention/treatment
Stroke Other: Telemedicine consultation system

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : November 2015
Groups and Cohorts
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Group/Cohort Intervention/treatment
Teleconsultation
Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares
 Other: Telemedicine consultation system
Telemedicine consultation system based on portable hardwares
Historical control
Usual stroke care without the guidance from hub hospital


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients treated with intravenous thrombolysis [ Time Frame: at 4.5 hours ]

Secondary Outcome Measures :
  1. Favorite outcome at 3 months (modified Rankin score ≤2) [ Time Frame: at 1 month/3 months ]
  2. Stroke complications [ Time Frame: 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.

  3. Fatal and nonfatal cardiovascular events [ Time Frame: at 7 days ]
    They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure

  4. All cause mortality [ Time Frame: at 3 months ]
  5. Time intervals [ Time Frame: 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.

  6. Length of hospitalization [ Time Frame: at 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088346


Contacts
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Contact: Ziwen Yuan, MD yuan0929rong@hotmail.com
Contact: Zhirong Liu, MD liuzhir@fmmu.edu.cn

Locations
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China, Shanxi
Xingyuan Hospital Recruiting
Yulin, Shanxi, China, 719000
Yulin First People's Hospital Not yet recruiting
Yulin, Shanxi, China, 719000
Yulin Second People's Hospital Recruiting
Yulin, Shanxi, China, 719000
Yuyang District People's Hospital Not yet recruiting
Yulin, Shanxi, China, 719000
Sponsors and Collaborators
Xijing Hospital
Department of Science and Technology of Shanxi Province
Air Force Military Medical University, China
Investigators
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Principal Investigator: Zhirong Liu, MD Xijing Hospital
Study Director: Gang Zhao, MD Xijing Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02088346    
Other Study ID Numbers: Xijing-Tele-001
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: September 2014
Keywords provided by Xijing Hospital:
Stroke
Thrombolysis
Tissue plasminogen activator
Urokinase
Telemedicine
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases