StrokeSSSSNCT02735226
Stroke Prevention and Treatment System in Shanghai: a Network of Public Healthcare of Stroke
An observational study of Stroke, run by Shanghai Stroke Service System at 11 sites in China.
Trial summary
The Shanghai Stroke Service System（4S） has been established as the network of stroke care in greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of 40 million in Shanghai. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- stroke network and policy intervention
- How many people
- 100,000 participants
- Where
- 11 sitesChina
- Study dates
- Jan 2014to Dec 2018
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with acute stroke are admitted to these 11 hospital in Shanghai for secondary prevention.
Who may be able to join
- 18 years old or older
- primary diagnosis as acute stroke or TIA within 7 days from onset
- admitted in stroke unit.
Who cannot join
- child or teenager younger than 18 years old
- woman with pregnant
- outpatient
- any other reason that patient cannot be admitted for secondary prevention
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 10 recruiting
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200030
Xin Wang, M.D.,Ph.D., 13501909896, wang.xin@zs-hospital.sh.cn
Xin Wang, M.D., Ph.D.
- Recruiting
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality, 200040
Qiang Dong, M.D., Ph.D., 86-13701875129, qiang_dong163@163.com
Yi Dong, M.D., 86-13916665674, drdongyi@yeah.net
- Recruiting
Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University
Shanghai, Shanghai Municipality, 200040
Xiaofei Yu, M.D.，Ph.D., 13331978806, doctorxiaoyu@sina.com
Xiaofei Yu, M.D.，Ph.D.
- Recruiting
The Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, 200072
Xueyuan Liu, 13564578127, lxyshtj@163.com
Xueyuan Liu, M.D.
- Recruiting
Dongfang Hospital affiliated to Shanghai University of TCM
Shanghai, Shanghai Municipality
Gang Li, M.D., 13621691786, ligang0531@yeah.net
Changsong Li, 13122751682, kite1107@126.com
- Recruiting
Renji hospital，Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Yangtai Guan, Ph.D., M.D., 13386271865, yangtaiguan@hotmail.com
Ying Chen, 13501763660, 13501763660@163.com
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Benqiang Deng, M.D., 13701936570, 13701936570@163.com
Benqiang Deng, M.D.
- Active, not recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality
- Recruiting
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality
Yi Fu, 86-021-64370045, fuyiki@sina.com
Shufen Chen, 1379532986, csf_cindy@hotmail.com
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jianren Liu, M.D., liujr021@vip.163.com, liujr021@vip.163.com
Jianren Liu, M.D.
- Recruiting
The Sixth People's Hospital affiliated to Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Yuwu Zhao, M.D., 15901713716, zhaoyuwu2005@126.com
Hongmei Wang, 18930177606, dd-tt12345@163.com
About this study
Official title: Shanghai Stroke Service System
The Shanghai Stroke Service System（4S） has been established as the network of stroke care in greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of 40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the effort of recovery and secondary stroke prevention. The novel electronic data aquisition system provides the contiguous data of clinical care of stroke patients from the acute phase of management to inpatient rehabilitation. This system has been implemented and maintained as an ongoing quality of stroke care project that monitored the process of routine stroke care in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family Planning. Our analysis of the project was approved by the Ethics Committee, which agreed that no written informed consents were needed since the study only was consisted of a population-based retrospective data analysis.
Read the detailed description
The goal of Shanghai stroke service system is to promote and facilitate high quality standardized stroke care in Shanghai area. The 11 hospitals involved are committed to provide the best stroke care to their patients. This quality goal consists of two parts: the acute phase of stroke care and the subsequent care during the hospitalization. To accomplish this goal, each hospital has organized a multidisciplinary stroke team that will address day-to-day stroke care. Each hospital provides prioritized neuroimaging service to patients with acute stroke 24hr per day, 7days per week. A stroke neurologist is on site 24hr per day, 7 days per week in each hospital. This team will follow the guidelines to carry out standardized secondary stroke prevention once the patient has been admitted.
The stroke clinical pathway is available on line in computers of each hospital. This pathway can be accessed from hospital computers, or from outside.
Stroke team members in each hospital obtained and entered all data on each stroke patient: demographics, stroke onset time, onset to thrombolytic time, presenting NIHSS, timing of diagnostic procedures, treatment strategies, performance of quality measures, comorbidities, in-hospital mortality, etc. These data are contained in a three-page form, which are embedded in the electronic health record of each patient.
If ICD-10 stroke codes were entered as the primary discharge diagnoses, the electronic health record systems would not allow the discharge of the patient until all required documentation has been completed. The EHR would not allow for any empty fields before it could be closed. Data quality was assured by automatic feasibility checks. The novel electronic data acquisition system provides the continuous clinical care data on all stroke patients from their acute management phase to inpatient rehabilitation or discharge.
- Conditions
- Stroke
- Being tested
- stroke network and policy intervention
- Keywords
- stroke, Shanghai Healthcare, Healthcare Quality, Access, and Evaluation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stroke network and policy interventionOther
Shanghai stroke service and network contributes to update the ability of stroke care of comprehensive and primary stroke center,to improve radiation ability of comprehensive stroke centers and try to form a close relationship between comprehensive stroke centers and its primary stroke centers.
| Study group | Role | What they receive |
|---|---|---|
| Acute Stroke patient | Patients who are presented to hospital within 7days from onset. The key measurement of clinical quality controlled in patients with acute stroke managment and inhouse stroke care were record automatically Receives: Other: stroke network and policy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The acute stroke service and treatment provided in Shanghai area
The phase of acute stroke therapy. Under this category, the acute stroke care specific quality measurement items are:
Stroke onset to hospital ER Time
Door to CT Time
Door to seen by a doctor Time
Door to IV TPA Time
Door to groin puncture time for IA therapy
Door to admission to a hospital bed Time
Measured: 5 years
The secondary prevention of stroke provided after discharge in Shanghai area
- Secondary stroke prevention prescribed.
Antithrombotics prescribed
Swallowing evaluation performed before oral feeding starts
DVT prophylaxis prescribed
Anticoagulation for atrial fibrillation prescribed
Brain imaging including vascular imaging performed
Stroke education provided
Educating patient to stop smoking
Statins prescribed
Rate of catheter related UTI
Rate of aspiration pneumonia
Hospital length of stay
Discharge destination
The time frame for this project is 5 years. All elements of acute stroke care will be collected during the hospital stay.
Measured: 5 years
Secondary outcomes (2)
To assess the rate of antiplatelet agent used for stroke prevention.
This would include the rate of patients being prescribed dual antiplatelet therapy, and the duration/compliance of taking antiplatelet medicine.
Measured: 5 years
To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation.
To assess the rate of bridging therapy used during hospitalization. Bridging therapy is to give intravenous or subcutaneous anticoagulation while waiting for warfarin to be therapeutic. In addition, the rate of prescribing new oral anticoagulants for stroke prevention in atrial fibrillation will be assessed,
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 100,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Stroke Service System
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, theTenth People's Hospital, the Sixth People's Hospital, RenJi Hospital, ShuGuang Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Changzheng Hospital, Changhai Hospital, the Ninth People's Hospital
- Responsible party
- Principal investigator, Qiang Dong, Shanghai Stroke Service System
- Investigators
- Qiang Dong, M.D., Ph.D, Principal investigator, Shanghai Stroke Service System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735226
- Sponsor's protocol ID
- Shanghai Stroke Service System
- Acronym
- SSSS
- Status last verified
- Jul 2017
- First submitted
- 31 Mar 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data is planning to make individual participant data available, especially to anticipating collaborator.
Publications
Han S, Xu J, Xie Y, Fang K, Hu L, Dong Y, Dong Q. Effect of a regional guideline-education initiative on dual antiplatelet therapy use in minor non-cardioembolic stroke: a pre-post analysis from the Shanghai Stroke Service System. Stroke Vasc Neurol. 2026 Feb 12:svn-2025-004815. doi: 10.1136/svn-2025-004815. Online ahead of print.
PubMed 41679778Xu J, Xie Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Xian Y, Shen H, Li H, Wang DZ, Campbell BC, Parsons MW, Dong Y, Dong Q. Effect of the Shanghai Stroke Service System (4S) on the quality of stroke care and outcomes: A prospective quality improvement project. Int J Stroke. 2023 Jun;18(5):599-606. doi: 10.1177/17474930221125993. Epub 2022 Oct 15.
PubMed 36082948Dong Y, Han Y, Shen H, Wang Y, Ma F, Li H, Wang Y, Dong Q. Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis. Stroke Vasc Neurol. 2020 Dec;5(4):348-352. doi: 10.1136/svn-2020-000388. Epub 2020 Jul 1.
PubMed 32611728Dong Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Wang P, Chen X, Shen H, Wang DZ, Xian Y, Feng W, Campbell BC, Parsons M, Dong Q. The network of Shanghai Stroke Service System (4S): A public health-care web-based database using automatic extraction of electronic medical records. Int J Stroke. 2018 Jul;13(5):539-544. doi: 10.1177/1747493018765492. Epub 2018 Mar 21.
PubMed 29561219
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Stroke Service System
- ClinicalTrials.gov ID
- NCT02735226
- Acronym / sponsor ID
- SSSS / Shanghai Stroke Service System
- Conditions
- Stroke
- Keywords
- stroke, Shanghai Healthcare, Healthcare Quality, Access, and Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Shanghai Stroke Service SystemUniversity, hospital or other
- Collaborators
- Huashan Hospital, Shanghai Zhongshan Hospital, Ruijin Hospital, theTenth People's Hospital, the Sixth People's Hospital, RenJi Hospital, ShuGuang Hospital, Dongfang Hospital Beijing University of Chinese Medicine, Changzheng Hospital, Changhai Hospital, the Ninth People's Hospital
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Apr 2016 (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 Shanghai Stroke Service System（4S） has been established as the network of stroke care in greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of 40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the effort of recovery and secondary stroke prevention. The novel electronic data aquisition system provides the contiguous data of clinical care of stroke patients from the acute phase of management to inpatient rehabilitation. This system has been implemented and maintained as an ongoing quality of stroke care project that monitored the process of routine stroke care in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family Planning. Our analysis of the project was approved by the Ethics Committee, which agreed that no written informed consents were needed since the study only was consisted of a population-based retrospective data analysis.
Detailed description
The goal of Shanghai stroke service system is to promote and facilitate high quality standardized stroke care in Shanghai area. The 11 hospitals involved are committed to provide the best stroke care to their patients. This quality goal consists of two parts: the acute phase of stroke care and the subsequent care during the hospitalization. To accomplish this goal, each hospital has organized a multidisciplinary stroke team that will address day-to-day stroke care. Each hospital provides prioritized neuroimaging service to patients with acute stroke 24hr per day, 7days per week. A stroke neurologist is on site 24hr per day, 7 days per week in each hospital. This team will follow the guidelines to carry out standardized secondary stroke prevention once the patient has been admitted.
The stroke clinical pathway is available on line in computers of each hospital. This pathway can be accessed from hospital computers, or from outside.
Stroke team members in each hospital obtained and entered all data on each stroke patient: demographics, stroke onset time, onset to thrombolytic time, presenting NIHSS, timing of diagnostic procedures, treatment strategies, performance of quality measures, comorbidities, in-hospital mortality, etc. These data are contained in a three-page form, which are embedded in the electronic health record of each patient.
If ICD-10 stroke codes were entered as the primary discharge diagnoses, the electronic health record systems would not allow the discharge of the patient until all required documentation has been completed. The EHR would not allow for any empty fields before it could be closed. Data quality was assured by automatic feasibility checks. The novel electronic data acquisition system provides the continuous clinical care data on all stroke patients from their acute management phase to inpatient rehabilitation or discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Stroke patient | – | Other: stroke network and policy interventionPatients who are presented to hospital within 7days from onset. The key measurement of clinical quality controlled in patients with acute stroke managment and inhouse stroke care were record automatically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with acute stroke are admitted to these 11 hospital in Shanghai for secondary prevention.
Key inclusion criteria (3 listed)
- 18 years old or older
- primary diagnosis as acute stroke or TIA within 7 days from onset
- admitted in stroke unit.
Key exclusion criteria (4 listed)
- child or teenager younger than 18 years old
- woman with pregnant
- outpatient
- any other reason that patient cannot be admitted for secondary prevention
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 |
|---|---|---|
| stroke network and policy interventionShanghai stroke service and network contributes to update the ability of stroke care of comprehensive and primary stroke center,to improve radiation ability of comprehensive stroke centers and try to form a close relationship between comprehensive stroke centers and its primary stroke centers. | Other | Acute Stroke patient |
Primary outcome
The acute stroke service and treatment provided in Shanghai area
Time frame: 5 years
The phase of acute stroke therapy. Under this category, the acute stroke care specific quality measurement items are: Stroke onset to hospital ER Time Door to CT Time Door to seen by a doctor Time Door to IV TPA Time Door to groin puncture time for IA therapy Door to admission to a hospital bed Time
The secondary prevention of stroke provided after discharge in Shanghai area
Time frame: 5 years
2. Secondary stroke prevention prescribed. Antithrombotics prescribed Swallowing evaluation performed before oral feeding starts DVT prophylaxis prescribed Anticoagulation for atrial fibrillation prescribed Brain imaging including vascular imaging performed Stroke education provided Educating patient to stop smoking Statins prescribed Rate of catheter related UTI Rate of aspiration pneumonia Hospital length of stay Discharge destination The time frame for this project is 5 years. All elements of acute stroke care will be collected during the hospital stay.
2 secondary outcomes
To assess the rate of antiplatelet agent used for stroke prevention.
Time frame: 5 years
To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 41679778Han S, Xu J, Xie Y, Fang K, Hu L, Dong Y, Dong Q. Effect of a regional guideline-education initiative on dual antiplatelet therapy use in minor non-cardioembolic stroke: a pre-post analysis from the Shanghai Stroke Service System. Stroke Vasc Neurol. 2026 Feb 12:svn-2025-004815. doi: 10.1136/svn-2025-004815. Online ahead of print.
- Derived from this study: PubMed 36082948Xu J, Xie Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Xian Y, Shen H, Li H, Wang DZ, Campbell BC, Parsons MW, Dong Y, Dong Q. Effect of the Shanghai Stroke Service System (4S) on the quality of stroke care and outcomes: A prospective quality improvement project. Int J Stroke. 2023 Jun;18(5):599-606. doi: 10.1177/17474930221125993. Epub 2022 Oct 15.
- Derived from this study: PubMed 32611728Dong Y, Han Y, Shen H, Wang Y, Ma F, Li H, Wang Y, Dong Q. Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis. Stroke Vasc Neurol. 2020 Dec;5(4):348-352. doi: 10.1136/svn-2020-000388. Epub 2020 Jul 1.
- Derived from this study: PubMed 29561219Dong Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Wang P, Chen X, Shen H, Wang DZ, Xian Y, Feng W, Campbell BC, Parsons M, Dong Q. The network of Shanghai Stroke Service System (4S): A public health-care web-based database using automatic extraction of electronic medical records. Int J Stroke. 2018 Jul;13(5):539-544. doi: 10.1177/1747493018765492. Epub 2018 Mar 21.
- Individual participant dataSharing planned: Yes. The data is planning to make individual participant data available, especially to anticipating collaborator.
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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.
Qiang Dong, M.D., Ph.D principal investigator
Shanghai Stroke Service System
11 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 Shanghai Stroke Service System at 11 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 3 inclusion and 4 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Yi Dong, M.D (86-21-52887145, drdongyi@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acute stroke service and treatment provided in Shanghai area (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02735226, which also lists 4 linked publications.
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 19 Jul 2017.