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

Not Applicable

• Conditions: Stroke
• Interventions: Device: AI-based CDSS

• Registration Number: NCT04524624
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24
• Study Start: 2020-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21689

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI-based CDSS	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)	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.
A composite measure score of performance measures	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.
Disability	3, 6, 12 months	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	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.
All-cause mortality	3, 6, 12 months	All-cause mortality

Trial Locations

Locations (1)

Beijing Tian tan Hospital; 🇨🇳 Beijing, Beijing, China