NCT06005636

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
985

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 17, 2023

Last Update Submit

August 17, 2023

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • post-stroke delirium

    The first week of admission

Study Arms (2)

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

Test delirium stateDIAGNOSTIC_TEST

use scale to test whether ischemic stroke patients have post-stroke delirium

with post-stroke deliriumwithout post-stroke delirium

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fengxia Yan

    Jinan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 22, 2023

Study Start

September 1, 2021

Primary Completion

September 10, 2022

Study Completion

April 27, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)