Acute Ischemic StrokeNCT05852080
Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate
A study testing multilevel system intervention based on information platform in people with Acute Ischemic Stroke and Stroke Recrudescence, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Stroke Recrudescence, Quality Improvement
- What is being tested?
- multilevel system intervention based on information platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients of 18 years or older.
- Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)
- Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
- Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).
Who cannot join
- Patients refuse to participate in this study.
- Patients who losing his medical record of having the incomplete medical record
Trial locations and contacts
1 site in 1 country.
China1 site
Min Lou
Hangzhou, Zhejiang, 310000
Zexin Chen, 13757118366, HREC2013@126.com
About this study
Official title: Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with <250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).
- Being tested
- multilevel system intervention based on information platform
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multilevel system intervention based on information platformBehavioural
- Standardized templates of medical record
- Continuous medical quality control and feedback system: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the percentage of stroke of undetermined cause.
- Team collaboration based on video conferencing: hospitals will receive corresponding suggestions for their improvement from experts online.
- Enhanced feedback incentives
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Hospitals in the intervention arm will receive a multilevel system intervention based on information platform Receives: Behavioral: multilevel system intervention based on information platform |
| control arm | No intervention | Hospitals in the control arm will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of new ischemic stroke events
To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
Measured: 1 year
Secondary outcomes (7)
Incidence rate of new ischemic stroke events
Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
Measured: 3, 5 years
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) at 1, 3, 5 years after initial symptom onset.
Measured: 1, 3, 5 years
All-cause mortality
All-cause mortality
Measured: 1, 3, 5 years
The percentage of stroke of undetermined cause at discharge
The percentage of stroke of undetermined cause at discharge
Measured: 1 year
Rate of antithrombotic therapy at discharge
The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.
Measured: 1 year
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period
Measured: 1 year
Rate of blood vessel assessment within one week of hospitalization
The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zexin Chen, Principal investigator, Tthe second affiliated hospital, school of medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852080
- Sponsor's protocol ID
- MISA
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05852080
- Acronym / sponsor ID
- MISA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 10 May 2023 (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.
A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with <250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Behavioral: multilevel system intervention based on information platformHospitals in the intervention arm will receive a multilevel system intervention based on information platform |
| control arm | No intervention | –Hospitals in the control arm will receive no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of 18 years or older.
- Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)
- Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
- Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).
Key exclusion criteria (2 listed)
- Patients refuse to participate in this study.
- Patients who losing his medical record of having the incomplete medical record
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 |
|---|---|---|
| multilevel system intervention based on information platform1. Standardized templates of medical record 2. Continuous medical quality control and feedback system: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the percentage of stroke of undetermined cause. 3. Team collaboration based on video conferencing: hospitals will receive corresponding suggestions for their improvement from experts online. 4. Enhanced feedback incentives | Behavioural | intervention arm |
Primary outcome
Incidence rate of new ischemic stroke events
Time frame: 1 year
To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
7 secondary outcomes
Incidence rate of new ischemic stroke events
Time frame: 3, 5 years
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
Time frame: 1, 3, 5 years
All-cause mortality
Time frame: 1, 3, 5 years
The percentage of stroke of undetermined cause at discharge
Time frame: 1 year
Rate of antithrombotic therapy at discharge
Time frame: 1 year
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
Time frame: 1 year
Rate of blood vessel assessment within one week of hospitalization
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Zexin Chen principal investigator
Tthe second affiliated hospital, school of medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multilevel system intervention based on information platform in people with Acute Ischemic Stroke and Stroke Recrudescence, 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 4 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 10 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD (+8613958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of new ischemic stroke events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.