NCT04524624

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,689

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 24, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

August 7, 2020

Last Update Submit

August 20, 2020

Conditions

Stroke

Keywords

acute ischemic strokeartificial intelligenceclinical decision support systemcluster randomized controlled trialevidence-based performance

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (5)

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

    6, 12 months

  • Disability

    3, 6, 12 months

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

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

  • A composite measure score of performance measures

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

  • All-cause mortality

    3, 6, 12 months

Other Outcomes (12)

  • Moderate and severe bleeding events according to the GUSTO criteria

    3, 6, 12 months

  • All bleeding events

    3, 6, 12 months

  • Intracranial hemorrhagic events

    3, 6, 12 months

  • +9 more other outcomes

Study Arms (2)

AI-based CDSS

EXPERIMENTAL

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.

Device: AI-based CDSS

Usual Care

NO INTERVENTION

Usual Care

Interventions

AI-based CDSSDEVICE

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.

AI-based CDSS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tian tan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (2)

  • 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.

    PMID: 29959443BACKGROUND

  • 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.

    PMID: 37699726DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yongjun Wang, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zixiao Li, MD

CONTACT

00861013683234256lizixiao2008@hotmail.com

Lingling Ding, MD

CONTACT

00861013552358752dll_ing@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2020

First Posted

August 24, 2020

Study Start

September 1, 2020

Primary Completion

September 30, 2022

Study Completion

June 30, 2023

Last Updated

August 24, 2020

Record last verified: 2020-08

Locations

CN(1)