Acute Stroke Advancing Program Using Telemedicine "ASAP-Tel"

Recruiting

Phase N/A Results N/A

Update History

26 Jun '15
The Summary of Purpose was updated.
New
The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.
Old
The objective is to evaluate whether decision making of intravenous thrombolysis within 4.5 hours after stroke onset via telemedicine consultation system can elevate the percentage of patients treated with intravenous thrombolysis, and improve the clinical outcomes at 3 months for acute ischemic stroke patients.
The description was updated.
New
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.
Old
For patients with ischemic stroke, the use of intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA) within 3 hours was approved by the US FDA in 1996, and now has been widely accepted. Based on the evidences from a few trials, the European Medicines Agency has expanded the time window of intravenous rt-PA to 4.5 hours, and the guideline from the American Heart Association/American Stroke Association has also given such a recommendation, although the US FDA declined to do so. In China, besides the use of rt-PA, intravenous urokinase within 6 hours has also been approved by China Food and Drug Administration (CFDA), and been recommended by "2010 Chinese Guidelines for the Management of Acute Ischemic Stroke", supported by the evidence from a series of trials about intravenous urokinase thrombolysis. And urokinase is used more frequently than rt-PA, mainly because urokinase is cheaper, and rt-PA is not included in the drug catalogue of medical insurance in China. Therefore, in our trial, urokinase also can be used for eligible ischemic stroke patients depended on the patients' choice, and its time window for treatment will also be restricted within 4.5 hours after stroke onset. Until now, the rate of intravenous thrombolysis with rt-PA or urokinase is still very low. Usually, these stroke patients would be translated to the local hospital firstly. However, for lack of local expertise and infrastructure, intravenous thrombolysis was not always conducted even if the patients met the criteria. There is good evidence that telemedicine may help resolve the shortage of local expertise in neurology and improve the stroke care quality in the remote regions. Another main challenge is the narrow time window for fibrinolytic therapy. For stroke patients, it is extremely important to restore blood flow of the ischemic area as soon as possible. And it has also been approved that telemedicine may significantly shorten the time to initiate specific treatment. Until now, there's still no study evaluating the efficacy and reliability of telestroke in China. Thus, we introduced this telemedicine model into the nonspecialized hospitals in the remote areas in China. The objective is to evaluate whether decision making of intravenous thrombolysis via telemedicine consultation system can elevate the percentage of patients treated with intravenous thrombolysis, and improve the clinical outcomes at 3 months for acute ischemic stroke patients. 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 clients--tablet computer or smartphone, which is designed by School of Biomedical Engineering in the Fourth Military Medical University. 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 trial. After that, the teleconsultation system will be introduced. Once the physician in one of the spoke hospitals judged his patient as acute ischemic stroke, he will call the telemedicine consultation system. Then one expert in the hub hospitals will ensure the diagnosis of acute ischemic stroke, assess the conditions of the patient and determine whether intravenous thrombolysis should be conducted; and will also give recommendations for other treatments. During the 9 months study period, about 300 ischemic stroke patients may potentially be included.
A location was updated in Yulin.
New
The overall status was updated to "Recruiting" at Xingyuan Hospital.
A location was updated in Yulin.
New
The overall status was updated to "Recruiting" at Yulin Second People's Hospital.