An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II)

August 20, 2020 updated by: Yongjun Wang, Beijing Tiantan Hospital

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

This study will conduct a cluster randomized controlled trial to evaluate the impact of an artificial intelligence-based clinical decision support system for the integrated management of patients with acute ischemic stroke on the adherence to guideline-based therapies and the incidence of new clinical vascular events.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

21689

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lingling Ding, MD
  • Phone Number: 00861013552358752
  • Email: dll_ing@sina.com

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tian Tan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: AI-based CDSS
  1. Automatically identifying acute ischemic stroke lesions on DWI.
  2. Classification of stroke subtypes and mechanisms.
  3. Evidence-based alerts and guidelines for early stroke management.
  4. Guideline-recommended secondary stroke prevention strategies.
  1. Automatically identifying acute ischemic stroke lesions on DWI.
  2. Classification of stroke subtypes and mechanisms.
  3. Evidence-based alerts and guidelines for early stroke management.
  4. Guideline-recommended secondary stroke prevention strategies.

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
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.
3 months

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
Disability
Time Frame: 3, 6, 12 months
Degree of disability (measured by the Modified Rankin Scale) at discharge, 3, 6, and 12 months
3, 6, 12 months
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
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.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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
All-cause mortality
Time Frame: 3, 6, 12 months
All-cause mortality
3, 6, 12 months

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
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
3, 6, 12 months
All bleeding events
Time Frame: 3, 6, 12 months
All bleeding events (severe/moderate bleeding and intracranial hemorrhage)
3, 6, 12 months
Intracranial hemorrhagic events
Time Frame: 3, 6, 12 months
Intracranial hemorrhagic events
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
We calculated home time as total days alive and not in a hospital or skilled nursing facility.
3, 6, 12 months
All-cause readmission
Time Frame: 3, 6, 12 months
All-cause readmission
3, 6, 12 months
Ischemic stroke readmission
Time Frame: 3, 6, 12 months
Ischemic stroke readmission
3, 6, 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: yongjun wang, MD, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Stroke

Clinical Trials on AI-based CDSS

3
Subscribe