StrokeASAP-TelNCT02088346
Acute Stroke Advancing Program Using Telemedicine
An observational study of Stroke, run by Xijing Hospital at 4 sites in China.
Trial summary
The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Telemedicine consultation system
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset
Who may be able to join
- 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
Who cannot join
- Time of symptom onset unclear
- Unlikely to complete study through 3-month follow-up
Trial locations and contacts
4 sites in 1 country.
Ziwen Yuan, MD contact
Zhirong Liu, MD contact
China4 sites, 4 recruiting
- Recruiting
Xingyuan Hospital
Yulin, Shanxi, 719000
- Not yet recruiting
Yulin First People's Hospital
Yulin, Shanxi, 719000
- Recruiting
Yulin Second People's Hospital
Yulin, Shanxi, 719000
- Not yet recruiting
Yuyang District People's Hospital
Yulin, Shanxi, 719000
About this study
Official title: Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
The purpose is to evaluate the effectiveness and safety profile of telemedicine consultation system in making decision on IV thrombolysis.
Read the 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
- Stroke
- Being tested
- Telemedicine consultation system
- Keywords
- Stroke, Thrombolysis, Tissue plasminogen activator, Urokinase, Telemedicine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine consultation systemOther
Telemedicine consultation system based on portable hardwares
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation | Intravenous thrombolysis guided by telemedicine consultation system based on portable hardwares Receives: Other: Telemedicine consultation system | |
| Historical control | Usual stroke care without the guidance from hub hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients treated with intravenous thrombolysis
Measured: at 4.5 hours
Secondary outcomes (6)
Favorite outcome at 3 months (modified Rankin score ≤2)
Measured: at 1 month/3 months
Stroke complications
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.
Measured: at 24 hours/7days
Fatal and nonfatal cardiovascular events
They include recurrent ischemic stroke, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attack, myocardial infarction, angina and heart failure
Measured: at 7 days
All cause mortality
Measured: at 3 months
Time intervals
Those from stroke onset to arriving in emergency department(ED), and from arriving in ED to physician/CT initiation/CT interpretation/specific treatment.
Measured: at 24 hours
Length of hospitalization
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology of Shanxi Province, Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Zhirong Liu, MD, Principal investigator, Xijing HospitalGang Zhao, MD, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088346
- Sponsor's protocol ID
- Xijing-Tele-001
- Acronym
- ASAP-Tel
- Status last verified
- Sep 2014
- First submitted
- 27 Feb 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25979867
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Thrombolysis Guided by Telemedicine Consultation System for Acute Ischemic Stroke Patients in China
- ClinicalTrials.gov ID
- NCT02088346
- Acronym / sponsor ID
- ASAP-Tel / Xijing-Tele-001
- Conditions
- Stroke
- Keywords
- Stroke, Thrombolysis, Tissue plasminogen activator, Urokinase, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Department of Science and Technology of Shanxi Province, Air Force Military Medical University, China
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | – | Other: Telemedicine consultation systemIntravenous thrombolysis guided by telemedicine consultation system based on portable hardwares |
| Historical control | – | –Usual stroke care without the guidance from hub hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients arriving in the local hospitals within 4.5 hours of symptom onset
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Time of symptom onset unclear
- Unlikely to complete study through 3-month follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine consultation systemTelemedicine consultation system based on portable hardwares | Other | Teleconsultation |
Primary outcome
Percentage of patients treated with intravenous thrombolysis
Time frame: at 4.5 hours
6 secondary outcomes
Favorite outcome at 3 months (modified Rankin score ≤2)
Time frame: at 1 month/3 months
Stroke complications
Time frame: at 24 hours/7days
Fatal and nonfatal cardiovascular events
Time frame: at 7 days
All cause mortality
Time frame: at 3 months
Time intervals
Time frame: at 24 hours
Length of hospitalization
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Derived from this study: PubMed 25979867Yuan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziwen Yuan, MD contact
Zhirong Liu, MD contact
Zhirong Liu, MD principal investigator
Xijing Hospital
Gang Zhao, MD study director
Xijing Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Xijing Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziwen Yuan, MD (yuan0929rong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients treated with intravenous thrombolysis (time frame: at 4.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.