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

NCT ID: NCT04524624

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 21689 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-06-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

AI-based CDSS

Intervention Type: DEVICE

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.

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Beijing Tian tan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zixiao Li, MD

Role: CONTACT

lizixiao2008@hotmail.com

00861013683234256

Lingling Ding, MD

Role: CONTACT

dll_ing@sina.com

00861013552358752

References

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.

Reference Type: BACKGROUND

PMID: 29959443 (View on PubMed)

Li Z, Zhang X, Ding L, Jing J, Gu HQ, Jiang Y, Meng X, Du C, Wang C, Wang M, Xu M, Zhang Y, Hu M, Li H, Gong X, Dong K, Zhao X, Wang Y, Liu L, Xian Y, Peterson E, Fonarow GC, Schwamm LH, Wang Y. Rationale and design of the GOLDEN BRIDGE II: a cluster-randomised multifaceted intervention trial of an artificial intelligence-based cerebrovascular disease clinical decision support system to improve stroke outcomes and care quality in China. Stroke Vasc Neurol. 2024 Dec 30;9(6):723-729. doi: 10.1136/svn-2023-002411.

Reference Type: DERIVED

PMID: 37699726 (View on PubMed)

Other Identifiers

KY 2020-016-02

Identifier Type: -

Identifier Source: org_study_id