- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06730711
Association Between Blood Pressure and Risk of PSCI
December 8, 2024 updated by: Dingqun Bai, First Affiliated Hospital of Chongqing Medical University
Association Between Blood Pressure and the Risk of Post-stroke Cognitive Impairment: a Retrospective Cohort Study
This retrospective cohort study was designed to explore the relationship between blood pressure and cognitive impairment after stroke
Study Overview
Status
Recruiting
Conditions
Detailed Description
Patients who have been followed up for more than 3 months after stroke will be included in the study.
Basic data of patients and factors that may be related to cognitive impairment will be collected, and the relationship between blood pressure and cognitive impairment after stroke will be explored by univariate regression analysis and multivariate regression analysis.
Univariate logistic regression model and multivariate logistic regression model were used to explore the relationship between blood pressure level and the risk of cognitive impairment after stroke, and the effect of blood pressure level and cognitive impairment sub-line in different patients was evaluated by subgroup analysis.
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Defei Chen
- Phone Number: +8615188017034
- Email: 2283273437@qq.com
Study Contact Backup
- Name: Dingqun Bai
- Phone Number: 13808380876
- Email: baidingqun@hospital.cqmu.edu.cn
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China
- Recruiting
- First Affiliated Hospital of Chongqing Medical University
-
Contact:
- Defei Chen
- Phone Number: +8617347917488
- Email: 2283273437@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Stroke patients admitted to the First Branch of the First Affiliated Hospital of Chongqing Medical University between 2022 and 2024 were retrospectively reviewed.
Description
Inclusion criteria:
- Patient diagnosed with stroke by CT or MRI,
- Patients completed the MMSE scale at least once during hospitalization
- The follow-up time was more than three months after the stroke occurred;
Exclusion criteria:
- Patients with incomplete data, follow-up time less than three months after the stroke occurred less than 3 months,
- Patients with pre-existing cognitive impairment before stroke according to their medical records,
- patients failed to complete MMSE assessment because of aphasia or any other reasons,
- Patients combined with malignant tumors, patients combined with psychiatric disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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NPSCI
NPSCI was defined as a score of MMSE≥26.
|
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PSCI
The prime outcome PSCI was defined as the cognitive impairment occurred after stroke and was still present three months after stroke and cognitive impairment was defined as a score of MMSE<26.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental State Examination Scale (MMSE)
Time Frame: Mini-Mental State Examination (MMSE) assessment will be completeed at 3 monthes after stroke
|
Global cognitive function assessment.
Easy to use and one of the most used scales to screen person with cognitive impairment in the world.
The minimum and maximum values range from 0 to 30.
Higher score means better cognition level.
|
Mini-Mental State Examination (MMSE) assessment will be completeed at 3 monthes after stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
December 2, 2024
First Submitted That Met QC Criteria
December 8, 2024
First Posted (Estimated)
December 12, 2024
Study Record Updates
Last Update Posted (Estimated)
December 12, 2024
Last Update Submitted That Met QC Criteria
December 8, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20241202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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