Acute Stroke Advancing Program Using Telemedicine "ASAP-Tel"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Telemedicine Other
    Intervention Desc: Telemedicine consultation system based on portable clients
    ARM 1: Kind: Experimental
    Label: Telemedicine
    Description: Telemedicine consultation system based on portable clients
  • Telemedicine consultation system Other
    Intervention Desc: Telemedicine consultation system based on portable hardwares
    ARM 1: Kind: Experimental
    Label: Teleconsultation
    Description: Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment
  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset

Outcomes

Type Measure Time Frame Safety Issue
Primary Percentage of patients treated with intravenous thrombolysis at 24 hours No
Secondary Favorite outcome at 3 months (modified Rankin score ≤2) at 3 months No
Secondary Symptomatic intracranial hemorrhage (sICH) at 7 days Yes
Secondary All cause mortality at 3 months No
Secondary Stroke complications at 24 hours/7days Yes
Secondary Fatal and nonfatal cardiovascular events at 7 days Yes
Secondary Time intervals at 24 hours No
Secondary Length of hospitalization at 3 months No

Sponsors