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

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

AI-based CDSS

About this trial

This is an interventional prevention trial for Stroke focused on measuring acute ischemic stroke, artificial intelligence, clinical decision support system, cluster randomized controlled trial, evidence-based performance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Tian tan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AI-based CDSS

Usual Care

Arm Description

Automatically identifying acute ischemic stroke lesions on DWI. Classification of stroke subtypes and mechanisms. Evidence-based alerts and guidelines for early stroke management. Guideline-recommended secondary stroke prevention strategies.

Usual Care

Outcomes

Primary Outcome Measures

Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)

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.

Secondary Outcome Measures

Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)

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.

Disability

Degree of disability (measured by the Modified Rankin Scale) at discharge, 3, 6, and 12 months

All-or-none measure of evidence-based performance measures

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.

A composite measure score of performance measures

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.

All-cause mortality

Full Information

NCT ID

NCT04524624

First Posted

August 7, 2020

Last Updated

August 20, 2020

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04524624

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

acute ischemic stroke, artificial intelligence, clinical decision support system, cluster randomized controlled trial, evidence-based performance

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

21689 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AI-based CDSS

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Usual Care

Intervention Type

Device

Intervention Name(s)

AI-based CDSS

Intervention Description

Primary Outcome Measure Information:

Title

Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)

Description

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.

Time Frame

6, 12 months

Title

Disability

Description

Degree of disability (measured by the Modified Rankin Scale) at discharge, 3, 6, and 12 months

Time Frame

3, 6, 12 months

Title

All-or-none measure of evidence-based performance measures

Description

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Title

A composite measure score of performance measures

Description

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.

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Title

All-cause mortality

Description

All-cause mortality

Time Frame

3, 6, 12 months

Other Pre-specified Outcome Measures:

Title

Moderate and severe bleeding events according to the GUSTO criteria

Description

Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.

Time Frame

3, 6, 12 months

Title

All bleeding events

Description

All bleeding events (severe/moderate bleeding and intracranial hemorrhage)

Time Frame

3, 6, 12 months

Title

Intracranial hemorrhagic events

Description

Intracranial hemorrhagic events

Time Frame

3, 6, 12 months

Title

Total costs of care

Description

Total costs of care

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Title

Average length of stay

Description

Average length of stay

Time Frame

Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Title

Home time

Description

We calculated home time as total days alive and not in a hospital or skilled nursing facility.

Time Frame

3, 6, 12 months

Title

All-cause readmission

Description

All-cause readmission

Time Frame

3, 6, 12 months

Title

Ischemic stroke readmission

Description

Ischemic stroke readmission

Time Frame

3, 6, 12 months

Title

Hemorrhagic stroke readmission

Description

Hemorrhagic stroke readmission

Time Frame

3, 6, 12 months

Title

Cardiovascular readmission

Description

Cardiovascular readmission

Time Frame

3, 6, 12 months

Title

Adverse events

Description

Adverse events

Time Frame

3, 6, 12 months

Title

Stratified analysis

Description

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.

Time Frame

3, 6, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zixiao Li, MD

Phone

00861013683234256

lizixiao2008@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lingling Ding, MD

Phone

00861013552358752

dll_ing@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongjun Wang, MD

Organizational Affiliation

Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tian tan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

29959443

Citation

Wang Y, Li Z, Zhao X, Wang C, Wang X, Wang D, Liang L, Liu L, Wang C, Li H, Shen H, Bettger J, Pan Y, Jiang Y, Yang X, Zhang C, Han X, Meng X, Yang X, Kang H, Yuan W, Fonarow GC, Peterson ED, Schwamm LH, Xian Y, Wang Y; GOLDEN BRIDGE-AIS Investigators. Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial. JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802.

Results Reference

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

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