- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882123
Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients
May 21, 2023 updated by: Xin Guo
The investigators continuously collected data from 482 AIS inpatients at the Neurology Department of Hebei General Hospital.
Both demographic and clinical data were collected from the study subjects.
Different head magnetic resonance imaging sequences were used to assess the subjects' CMBs, white matter lesions, and old lacunar infarcts (LI).
Various statistical methods, including the t-test, χ2 test, and logistic regression, were used to analyze the gender heterogeneity of the influencing factors for CMBs in AIS patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
482
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
Non-Probability Sample
Study Population
In this study, the data of patients with AIS who were admitted to the Department of Neurology of Hebei Provincial People's Hospital from January 2014 to December 2015 were continuously collected.
Description
Inclusion Criteria:
- Aged 18 years and older
- Must meet the diagnostic criteria for AIS as presented in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2014
- Must be in good physical condition and have the ability to cooperate with MRI examinations
- Must have underwent SWI
Exclusion Criteria:
- MRI contraindications present, such as cardiac pacemaker, cardiac stents, or metal implants
- Head MRI or carotid artery ultrasound suggests the presence of severe stenosis or occlusion in the intracranial or extracranial segments of the cerebral arteries
- Severe comorbid diseases, such as cardiac, pulmonary, hepatic, and renal insufficiencies
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 |
Intervention / Treatment |
---|---|
Comparison of clinical data between AIS patients in CMB and non-CMB groups
|
|
without CMBs; with CMBs
|
Whether patients with acute ischemic stroke are complicated by cerebral microbleeds
|
male; female
|
Whether patients with acute ischemic stroke are complicated by cerebral microbleeds
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of clinical data between AIS patients in CMB and non-CMB groups
Time Frame: from January 2014 to December 2015
|
Differences in general information between AIS patients in CMB and non-CMB groups
|
from January 2014 to December 2015
|
Comparison of clinical data between male and female AIS patients
Time Frame: from January 2014 to December 2015
|
Differences in general informationbetween male and female AIS patients
|
from January 2014 to December 2015
|
Comparison of CMB-related characteristics between the male and female AIS patients
Time Frame: from January 2014 to December 2015
|
Differences in CMB-related characteristics between the male and female AIS patients
|
from January 2014 to December 2015
|
Predictive factor analysis for CMBs in male AIS patients
Time Frame: from January 2014 to December 2015
|
CMB-related factors in male AIS patients
|
from January 2014 to December 2015
|
Predictive factor analysis for CMBs in female AIS patients
Time Frame: from January 2014 to December 2015
|
CMB-related factors in female AIS patients
|
from January 2014 to December 2015
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 11, 2023
First Submitted That Met QC Criteria
May 21, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 21, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220642
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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