Ischemic StrokeNCT06005636
Post-stroke Delirium in Ischemic Stroke Patients
An observational study of Ischemic Stroke, run by Jinan University Guangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Test delirium state
- How many people
- 985 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 27 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.
Who may be able to join
- aged ≥18 years old;
- ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;
- patients or their agencies agree to participate in this study.
Who cannot join
- brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;
- history of serious mental illness such as schizophrenia;
- unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;
- be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation [Richmond Agitation Sedation Scale (RASS)<-3 points], and do not ameliorate during study;
- with incomplete data.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
About this study
Official title: Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Test delirium state
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test delirium stateDiagnostic test
use scale to test whether ischemic stroke patients have post-stroke delirium
| Study group | Role | What they receive |
|---|---|---|
| with post-stroke delirium | ischemic stroke patients with post-stroke delirium Receives: Diagnostic Test: Test delirium state | |
| without post-stroke delirium | ischemic stroke patients without post-stroke delirium Receives: Diagnostic Test: Test delirium state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with post-stroke delirium
Measured: The first week of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2021
- Primary completion10 Sep 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Responsible party
- Principal investigator, Xiaoyan Cai, Jinan University Guangzhou
- Investigators
- Fengxia Yan, Principal investigator, Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005636
- Sponsor's protocol ID
- KY-2021-106
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Risk Prediction Model for Post-stroke Delirium in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT06005636
- Acronym / sponsor ID
- KY-2021-106
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 985 participants (actual)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Jinan University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with post-stroke delirium | – | Diagnostic Test: Test delirium stateischemic stroke patients with post-stroke delirium |
| without post-stroke delirium | – | Diagnostic Test: Test delirium stateischemic stroke patients without post-stroke delirium |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ischemic stroke patients were recruited from a Grade 3A hospital in Southern China.
Key inclusion criteria (3 listed)
- aged ≥18 years old;
- ischemic stroke, confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) scans;
- patients or their agencies agree to participate in this study.
Key exclusion criteria (5 listed)
- brain dysfunction caused by non-vascular causes such as traumatic brain injury, brain tumor or metastatic brain tumor;
- history of serious mental illness such as schizophrenia;
- unable to cooperate to the assessment as deafness, blindness, aphasia, dysarthria;
- be in coma [Glasgow Coma Scale (GCS)≤8 points] or sedation [Richmond Agitation Sedation Scale (RASS)<-3 points], and do not ameliorate during study;
- with incomplete data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test delirium stateuse scale to test whether ischemic stroke patients have post-stroke delirium | Diagnostic test | with post-stroke delirium, without post-stroke delirium |
Primary outcome
Number of Participants with post-stroke delirium
Time frame: The first week of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengxia Yan principal investigator
Jinan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Jinan University Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with post-stroke delirium (time frame: The first week of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.