StrokeNCT06730711
Association Between Blood Pressure and Risk of PSCI
An observational study of Stroke and Cognitive Decline, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This retrospective cohort study was designed to explore the relationship between blood pressure and cognitive impairment after stroke Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Cognitive Decline, Blood Pressure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Defei Chen, +8617347917488, 2283273437@qq.com
About this study
Official title: 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
Read the 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.
- Conditions
- Stroke, Cognitive Decline, Blood Pressure
- Keywords
- stroke, cognitive impairment, blood pressure
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NPSCI | NPSCI was defined as a score of MMSE≥26. | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mental State Examination Scale (MMSE)
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.
Measured: Mini-Mental State Examination (MMSE) assessment will be completeed at 3 monthes after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Sep 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dingqun Bai, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730711
- Sponsor's protocol ID
- 20241202
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Blood Pressure and the Risk of Post-stroke Cognitive Impairment: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06730711
- Acronym / sponsor ID
- 20241202
- Conditions
- Stroke, Cognitive Decline, Blood Pressure
- Keywords
- stroke, cognitive impairment, blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Dec 2024 (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 retrospective cohort study was designed to explore the relationship between blood pressure and cognitive impairment after stroke
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPSCI | – | –NPSCI was defined as a score of MMSE≥26. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Stroke and Cognitive Decline, run by First Affiliated Hospital of Chongqing Medical University 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 4 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dingqun Bai (13808380876, baidingqun@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental State Examination Scale (MMSE) (time frame: Mini-Mental State Examination (MMSE) assessment will be completeed at 3 monthes after stroke). 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 12 Dec 2024.