Clinical trial NCT05852080: Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate
Official title: Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke
Stroke Recrudescence
Quality Improvement
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with \<250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).


Eligibility criteria: 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:

* Patients refuse to participate in this study.
* Patients who losing his medical record of having the incomplete medical record

Primary outcomes:
measure: Incidence rate of new ischemic stroke events
timeFrame: 1 year
Secondary outcomes:
measure: Incidence rate of new ischemic stroke events
timeFrame: 3, 5 years
measure: Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
timeFrame: 1, 3, 5 years
measure: All-cause mortality
timeFrame: 1, 3, 5 years
measure: The percentage of stroke of undetermined cause at discharge
timeFrame: 1 year
measure: Rate of antithrombotic therapy at discharge
timeFrame: 1 year
measure: Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
timeFrame: 1 year
measure: Rate of blood vessel assessment within one week of hospitalization
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Min Lou
state: Zhejiang
Study officials:
affiliation: Tthe second affiliated hospital, school of medicine, Zhejiang University, China
name: Zexin Chen
role: PRINCIPAL_INVESTIGATOR
References: