Acute Ischemic StrokeNCT05882123
Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients
An observational study of Acute Ischemic Stroke, run by Xin Guo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- cerebral microbleeds
- How many people
- 482 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- cerebral microbleeds
- Keywords
- Acute ischemic stroke, Cerebral microbleeds, Influencing factors, Gender heterogeneity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral microbleedsOther
Whether patients with acute ischemic stroke are complicated by cerebral microbleeds
| Study group | Role | What they receive |
|---|---|---|
| Comparison of clinical data between AIS patients in CMB and non-CMB groups | Not described | |
| without CMBs; with CMBs | Not described Receives: Other: cerebral microbleeds | |
| male; female | Not described Receives: Other: cerebral microbleeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical data between AIS patients in CMB and non-CMB groups
Differences in general information between AIS patients in CMB and non-CMB groups
Measured: from January 2014 to December 2015
Comparison of clinical data between male and female AIS patients
Differences in general informationbetween male and female AIS patients
Measured: from January 2014 to December 2015
Comparison of CMB-related characteristics between the male and female AIS patients
Differences in CMB-related characteristics between the male and female AIS patients
Measured: from January 2014 to December 2015
Predictive factor analysis for CMBs in male AIS patients
CMB-related factors in male AIS patients
Measured: from January 2014 to December 2015
Predictive factor analysis for CMBs in female AIS patients
CMB-related factors in female AIS patients
Measured: from January 2014 to December 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xin Guo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Guo, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882123
- Sponsor's protocol ID
- 20220642
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guo X, Xing Y, Teng Z, Shen Z, Guo X, Lv P, Tian S. Gender heterogeneity in the influencing factors for cerebral microbleeds in acute ischemic stroke patients. Curr Med Res Opin. 2023 Jul;39(7):1045-1054. doi: 10.1080/03007995.2023.2219581. Epub 2023 Jun 20.
PubMed 37259500
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05882123
- Acronym / sponsor ID
- 20220642
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Cerebral microbleeds, Influencing factors, Gender heterogeneity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Xin GuoUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 May 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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparison of clinical data between AIS patients in CMB and non-CMB groups | – | – |
| without CMBs; with CMBs | – | Other: cerebral microbleeds |
| male; female | – | Other: cerebral microbleeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| cerebral microbleedsWhether patients with acute ischemic stroke are complicated by cerebral microbleeds | Other | male; female, without CMBs; with CMBs |
Primary outcome
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
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
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
Predictive factor analysis for CMBs in male AIS patients
Time frame: from January 2014 to December 2015
CMB-related factors in male AIS patients
Predictive factor analysis for CMBs in female AIS patients
Time frame: from January 2014 to December 2015
CMB-related factors in female AIS patients
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 31 May 2023.
- Derived from this study: PubMed 37259500Guo X, Xing Y, Teng Z, Shen Z, Guo X, Lv P, Tian S. Gender heterogeneity in the influencing factors for cerebral microbleeds in acute ischemic stroke patients. Curr Med Res Opin. 2023 Jul;39(7):1045-1054. doi: 10.1080/03007995.2023.2219581. Epub 2023 Jun 20.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Xin Guo.
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 4 inclusion and 3 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of clinical data between AIS patients in CMB and non-CMB groups (time frame: from January 2014 to December 2015). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882123, which also lists 1 linked publication.
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 31 May 2023.