Post-stroke Delirium in Ischemic Stroke Patients | NCT06005636

Studies
Post-stroke Delirium in Ischemic Stroke Patients

NCT06005636

Sponsor

Jinan University Guangzhou

Status

Completed

Last Update Posted

Aug 22, 2023Actual

Enrollment

985Actual

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Test delirium state

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Sep 10, 2022Actual

Completion Date

Apr 27, 2023Actual

First Submitted Date

Aug 17, 2023

First Submission Date that Met QC Criteria

Aug 17, 2023

First Posted Date

Aug 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2023

Last Update Posted Date

Aug 22, 2023Actual

Name	Class
First Affiliated Hospital of Jinan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to investigate the predictors of post-stroke delirium, develop and validate a nomogram of post-stroke delirium in the ischemic stroke patients.

Detailed Description

Introduction: Post-stroke delirium (PSD) is associated with unfavorable prognosis. Effectively identifying risk factors of PSD and predicting PSD is of essential.

Methods: This is a prospective, single-centered, cohort study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

985Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
with post-stroke delirium		ischemic stroke patients with post-stroke delirium	Diagnostic Test: Test delirium state
without post-stroke delirium		ischemic stroke patients without post-stroke delirium	Diagnostic Test: Test delirium state

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test delirium state	Diagnostic Test	use scale to test whether ischemic stroke patients have post-stroke delirium	with post-stroke delirium without post-stroke delirium

Measure	Description	Time Frame
post-stroke delirium		The first week of admission

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged ≥18 years old;(2) ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;(3) patients or their agencies agree to participate in this study.

Exclusion Criteria:

brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;(2) history of serious mental illness such as schizophrenia;(3) unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;(4) be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation [Richmond Agitation Sedation Scale (RASS)<-3 points], and do not ameliorate during study;(5) with incomplete data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fengxia Yan	Jinan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital of Jinan University		Guangzhou	Guangdong	510630	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

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