Stroke, AcuteNCT04487340
Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
An observational study of Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All acute stroke patients who were admitted to hospital.
Who may be able to join
- Acute stroke patients
Who cannot join
- No
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Min Lou
Hangzhou, Zhejiang, 310000
Zexin Chen, 13757118366, HREC2013@126.com
About this study
In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.
Read the detailed description
This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.
- Conditions
- Stroke, Acute
- Being tested
- Education
- Keywords
- thrombolysis, thrombectomy, hospitalization
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Independence (mRS 0-2) at 1 year
Measured: 1 year
Secondary outcomes (6)
All-cause mortality at 1 year
Measured: 1 year
Brain hemorrhage at 24-72 hours after hospitalization
Measured: 72 hours
The incidence of recurrent stroke or other vascular events at 1 year
Measured: 1 year
Independence (mRS 0-2) at 5 year
Measured: 5 year
The incidence of recurrent stroke or other vascular events at 5 year
Measured: 5 year
All-cause mortality at 5 year
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Jan 2016
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, Huzhou Center Hospital, The Second Affiliated Hospital of Jiaxing University, Jinhua Center Hospital, Taizhou Hospital
- Responsible party
- Sponsor
- Investigators
- Min Lou, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487340
- Sponsor's protocol ID
- CASE II
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou H, Zhong W, Zhang T, Xu C, Zhong G, Xie G, Zhang B, Chen H, Wang E, Xu D, Cheng C, Yang J, Lou M, Yan S; CASE-II Study Group. Comparing Outcomes of Thrombectomy Versus Intravenous Thrombolysis Based on Middle Cerebral Artery M2 Occlusion Features. Stroke. 2024 Jun;55(6):1592-1600. doi: 10.1161/STROKEAHA.123.044986. Epub 2024 May 24.
PubMed 38787930Xue R, Zhong W, Zhou Y, He Y, Yan S, Chen Z, Wang J, Gong X, Lou M. Endovascular Treatment for Minor Acute Ischemic Strokes With Large Vessel Occlusion. J Am Heart Assoc. 2022 Dec 20;11(24):e027326. doi: 10.1161/JAHA.122.027326. Epub 2022 Dec 19.
PubMed 36533622Wang J, Zhang J, Gong X, Zhang W, Zhou Y, Lou M. Prediction of large vessel occlusion for ischaemic stroke by using the machine learning model random forests. Stroke Vasc Neurol. 2022 Apr;7(2):94-100. doi: 10.1136/svn-2021-001096. Epub 2021 Oct 26.
PubMed 34702747
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Online Database of Acute Stroke Patients for Stroke Management Quality Evaluation
- ClinicalTrials.gov ID
- NCT04487340
- Acronym / sponsor ID
- CASE II
- Conditions
- Stroke, Acute
- Keywords
- thrombolysis, thrombectomy, hospitalization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, Huzhou Center Hospital, The Second Affiliated Hospital of Jiaxing University, Jinhua Center Hospital, Taizhou Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 27 Jul 2020 (actual)
- 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.
In the past three decades, the burden of stroke has increased in China and has gradually become the leading cause of death. The data acquisition and medical quality management still need to be improved in China. The purpose of this study was to establish online database of acute stroke patients for stroke management quality evaluation in China.
Detailed description
This study is a prospective multi-center registration study. The data of acute ischemic stroke patients who underwent reperfusion therapy were registered on emergency platform. The data of stroke patients who were hospitalized were registered on stroke meidical quality control platform. The information including demographics, risk factors (history of hypertension, diabetes, stroke/TIA or atrial fibrillation, etc), prior antiplatelet usage, onset to door time (ODT), baseline National Institutes of Health Stroke Scale (NIHSS) score, baseline infarct core volume, laboratory data, ect were recorded. Clinical outcome at 3 months and 1 year was assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All acute stroke patients who were admitted to hospital.
Key inclusion criteria (1 listed)
- Acute stroke patients
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| EducationProvide each center with relevant education of guidelines, and help the clinicians to improve medical quality. | Behavioural | – |
Primary outcome
Independence (mRS 0-2) at 1 year
Time frame: 1 year
6 secondary outcomes
All-cause mortality at 1 year
Time frame: 1 year
Brain hemorrhage at 24-72 hours after hospitalization
Time frame: 72 hours
The incidence of recurrent stroke or other vascular events at 1 year
Time frame: 1 year
Independence (mRS 0-2) at 5 year
Time frame: 5 year
The incidence of recurrent stroke or other vascular events at 5 year
Time frame: 5 year
All-cause mortality at 5 year
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 38787930Zhou H, Zhong W, Zhang T, Xu C, Zhong G, Xie G, Zhang B, Chen H, Wang E, Xu D, Cheng C, Yang J, Lou M, Yan S; CASE-II Study Group. Comparing Outcomes of Thrombectomy Versus Intravenous Thrombolysis Based on Middle Cerebral Artery M2 Occlusion Features. Stroke. 2024 Jun;55(6):1592-1600. doi: 10.1161/STROKEAHA.123.044986. Epub 2024 May 24.
- Derived from this study: PubMed 36533622Xue R, Zhong W, Zhou Y, He Y, Yan S, Chen Z, Wang J, Gong X, Lou M. Endovascular Treatment for Minor Acute Ischemic Strokes With Large Vessel Occlusion. J Am Heart Assoc. 2022 Dec 20;11(24):e027326. doi: 10.1161/JAHA.122.027326. Epub 2022 Dec 19.
- Derived from this study: PubMed 34702747Wang J, Zhang J, Gong X, Zhang W, Zhou Y, Lou M. Prediction of large vessel occlusion for ischaemic stroke by using the machine learning model random forests. Stroke Vasc Neurol. 2022 Apr;7(2):94-100. doi: 10.1136/svn-2021-001096. Epub 2021 Oct 26.
- Individual participant dataSharing planned: Undecided
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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.
Min Lou, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independence (mRS 0-2) at 1 year (time frame: 1 year). 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 NCT04487340, which also lists 3 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 23 Nov 2022.