An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II) (NCT04524624) | Clinical Trial Compass
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An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II)
China21,689 participantsStarted 2020-09-01
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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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 de…
What they're measuring
1
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)