- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524624
An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II)
A Multi-centre, Cluster Randomized Controlled Trial of an Artificial Intelligence-Based Clinical Decision Support System for Integrated Management of Patients With Acute Ischemic Stroke: The GOLDEN BRIDGE II Trial
Study Overview
Detailed Description
Artificial intelligence (AI) and clinical decision support system (CDSS) have demonstrated great progress in the diagnosis and treatment of cerebrovascular diseases.CDSS can use computer technology to simulate and extend expert knowledge and empirical evidence in a timely and efficient manner. The combination of AI and CDSS is a potential solution to the shortage of medical resources and can improve the quality of and promote the standardization of medical services. At intervention sites, neurologists will receive support on use of the AI-based CDSS.
Aim: To evaluate the effectiveness of an AI-based CDSS for stroke management in patients with acute ischemic stroke within 7 days of symptom onset.
Intervention: An AI-based CDSS for an integrated management of patients with acute ischemic stroke. The strategy includes automatically identifying acute stroke lesions and lesion patterns, automated classification of stroke subtypes and mechanisms, evidence-based alerts, and guideline-recommended secondary stroke prevention strategies.
Eighty eligible hospitals in china, stratified by hospital capacity (secondary grade or tertiary) and economic-geographical regions (eastern, central, and western), will be randomized into either the CDSS group or the usual care group.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zixiao Li, MD
- Phone Number: 00861013683234256
- Email: lizixiao2008@hotmail.com
Study Contact Backup
- Name: Lingling Ding, MD
- Phone Number: 00861013552358752
- Email: dll_ing@sina.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100070
- Beijing Tian Tan Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Cluster Inclusion Criteria:
- Secondary or tertiary hospitals with an emergency department and neurologic wards that receive patients with AIS.
- Hospitals with available brain MRI scans (1.5T or 3.0T).
Patient Inclusion Criteria:
- 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).
Exclusion Criteria:
Cluster Exclusion Criteria:
- Grade-one hospitals and rural hospitals.
- The specialized hospitals, such as women and children specialist hospital and tumor hospital.
- Hospitals with less than 20 patients with suspected AIS per month.
Patient Exclusion Criteria:
- Diagnosed DWI negative stroke.
- Diagnosed other types of cerebrovascular diseases, such as transient ischaemic attack, hemorrhagic stroke, cerebral venous sinus thrombosis, and so on.
- Diagnosed non cerebral vascular disease, such as stroke mimic, seizures, central nervous system infections, metabolic encephalopathy, and so on.
- Received carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS).
- Involving in other investigational drug or device clinical trials.
- Patients with malignant disease and life expectancy of less than 3 months or patients who are unable to complete the study for other reasons.
- Women who are pregnant or postpartum (≤6 weeks).
- Patients refuse to participate in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
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Experimental: AI-based CDSS
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)
Time Frame: 3 months
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To evaluate the efficacy of AI-based CDSS in reducing the risk of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) at 3 months after initial symptom onset.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)
Time Frame: 6, 12 months
|
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) at discharge, 6,12-months after initial symptom onset.
|
6, 12 months
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Disability
Time Frame: 3, 6, 12 months
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Degree of disability (measured by the Modified Rankin Scale) at discharge, 3, 6, and 12 months
|
3, 6, 12 months
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All-or-none measure of evidence-based performance measures
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Proportion of prescription of evidence-based performance measures.
"All or none" measures including the evidence-based therapies: antithrombotic medication within 48 hours after symptom onset, dual antiplatelet therapy (aspirin and clopidogrel) started within 24 hours after symptom onset (NIHSS score ≤3), intensive statin therapy, antihypertensive, hypoglycemic medications, dysphagia screening, and deep vein thrombosis prophylaxis within 48 hours of admission.
Discharge therapies include: antithrombotics, lipid lowering agents, anticoagulants for atrial fibrilation or flutter, antihypertensive, and hypoglycemic medications.
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Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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A composite measure score of performance measures
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
The composite measure score was defined as the total number of eligible performance measures performed divided by the total number of performance measures for which a given patient was eligible.
|
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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All-cause mortality
Time Frame: 3, 6, 12 months
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All-cause mortality
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3, 6, 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate and severe bleeding events according to the GUSTO criteria
Time Frame: 3, 6, 12 months
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Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
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3, 6, 12 months
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All bleeding events
Time Frame: 3, 6, 12 months
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All bleeding events (severe/moderate bleeding and intracranial hemorrhage)
|
3, 6, 12 months
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Intracranial hemorrhagic events
Time Frame: 3, 6, 12 months
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Intracranial hemorrhagic events
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3, 6, 12 months
|
Total costs of care
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Total costs of care
|
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Average length of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Average length of stay
|
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
|
Home time
Time Frame: 3, 6, 12 months
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We calculated home time as total days alive and not in a hospital or skilled nursing facility.
|
3, 6, 12 months
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All-cause readmission
Time Frame: 3, 6, 12 months
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All-cause readmission
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3, 6, 12 months
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Ischemic stroke readmission
Time Frame: 3, 6, 12 months
|
Ischemic stroke readmission
|
3, 6, 12 months
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Hemorrhagic stroke readmission
Time Frame: 3, 6, 12 months
|
Hemorrhagic stroke readmission
|
3, 6, 12 months
|
Cardiovascular readmission
Time Frame: 3, 6, 12 months
|
Cardiovascular readmission
|
3, 6, 12 months
|
Adverse events
Time Frame: 3, 6, 12 months
|
Adverse events
|
3, 6, 12 months
|
Stratified analysis
Time Frame: 3, 6, 12 months
|
Efficacy endpoint will also be analyzed stratified by Hospital level(secondary hospitals/tertiary hospitals), economic-geographical regions (eastern, central, and western), stroke severity (NIHSS≤3/NIHSS>3) and stroke subtypes.
|
3, 6, 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY 2020-016-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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