Intracerebral HemorrhageNCT05687201
Effect of Apolipoprotein E on the Prognosis of Patients With Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
The purpose of this observational study was to compare perihematomal edema and short-term prognosis in patients with intracerebral hemorrhage carrying the APOE-ε3 and APOE-ε4 genes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This prospective cohort study on spontaneous ICH was conducted at the Affiliated Hospital of Guizhou Medical University from January 2020 to December 2023. The patients were diagnosed with ICH by CT scan and has APOE gene test results. Screening was performed according to the following inclusion criteria, and patients meeting the above criteria were divided into ApoE-ε3 and ApoE-ε4 groups according to APOE test results.
Who may be able to join
- Relevant diagnosis of supratentorial ICH was confirmed through unenhanced CT scanning.
- Patients were distinguished based on venous blood collection, with the presence of the ApoE-ε4 (ε2/ε4, ε3/ε4, ε4/ε4) gene (ApoE-ε4 genotype) and patients harboring the ApoE-ε3 (ε3/ε3) gene (non-ApoE-ε4 genotype).
Who cannot join
- Patients with infratentorial ICH.
- Patients with ApoE-ε2 (ε2/ε2) based on venous blood collections.
- Younger than 18 years of age.
- ICH caused by trauma, anticoagulation therapy, or antiplatelet therapy.
- Patients admitted to the hospital with diseases that might impact inflammatory responses, such as infective meningitis and systemic infections.
- Patients with previous residual neurological deficits following a stroke.
- Patients with combined tumours, severe liver and kidney dysfunction, cardiac insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Apolipoprotein E4 on Perihematomal Edema and Short-term Prognosis in Patients With Intracerebral Hemorrhage
The purpose of this observational study was to compare perihematomal edema and short-term prognosis in patients with intracerebral hemorrhage carrying the APOE-ε3 and APOE-ε4 genes. The main questions it aims to answer are:
- Exploring whether patients carrying the ApoE-ε4 gene have more perifocal perihematomal edema after intracerebral hemorrhage than patients with the ApoE-ε3 gene.
- ApoEε4 gene has worse short-term prognosis than ApoEε3 gene in intracerebral hemorrhage patients.
All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.Some ICH patients were evaluated for Stereotactic minimally invasive surgery (sMIS) treatment by two experienced neurosurgeons.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)
- Keywords
- Intracerebral Hemorrhage, Apolipoprotein E gene, Perihematomal edema, Outcome
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)Diagnostic test
Non-surgical patients were followed up by CT on days 1 and 5-7 after ICH, and by CT or MRI on day 5-7. Surgical patients were followed up by CT before surgery and then transferred to the operating room. The first postoperative follow-up CT scan was performed on the second day after surgery, and the second postoperative CT scan was performed on the third day after surgery. Some patients need a third or even a fourth CT follow-up after surgery. The CT scan can be repeated at any time if the patient has neurologic deterioration.
| Study group | Role | What they receive |
|---|---|---|
| APOE-E4 (ε2/ε4,ε3/ε4,ε4/ε4) group | All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. Receives: Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI) | |
| APOEε3(ε3/ε3) group | All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. Receives: Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
One month after ICH
Telephone follow-up by experienced neurologist.Defining a modified Rankin Scale (mRS) score of 0-3 at discharge was considered to be a good prognosis. If the mRS score was >3, the prognosis was considered poor.
Measured: A maximum of 1 month was assessed from the date of randomization to the date of the first record of progression or death from any cause, whichever came first.
Volume of perihematoma edema
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Measured: Within 24 hours of ICH
Changes in the volume of perihematoma edema
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Measured: Days 5-7 after ICH
Secondary outcomes (1)
Venous blood indicators
Indicators of venous blood leukocytes, neutrophils and blood lymphocytes (10^9/L) were analysed.
Measured: Within 24 hours of the onset of ICH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Jan 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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 Intracerebral HemorrhageStudies 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Huang, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687201
- Sponsor's protocol ID
- HL970570
- Status last verified
- Aug 2024
- First submitted
- 21 Dec 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang L, Wu Q, Ye F, Che W, Zhao X, Yang C, Ren S, Wu G, Wang L. Apolipoprotein E-epsilon4 allele is associated with perihematomal brain edema and poor outcomes in patients with intracerebral hemorrhage. Sci Rep. 2025 Feb 16;15(1):5682. doi: 10.1038/s41598-025-89868-3.
PubMed 39956815
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apolipoprotein E4 on Perihematomal Edema and Short-term Prognosis in Patients With Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT05687201
- Acronym / sponsor ID
- HL970570
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Apolipoprotein E gene, Perihematomal edema, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 18 Jan 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 purpose of this observational study was to compare perihematomal edema and short-term prognosis in patients with intracerebral hemorrhage carrying the APOE-ε3 and APOE-ε4 genes. The main questions it aims to answer are:
- Exploring whether patients carrying the ApoE-ε4 gene have more perifocal perihematomal edema after intracerebral hemorrhage than patients with the ApoE-ε3 gene.
- ApoEε4 gene has worse short-term prognosis than ApoEε3 gene in intracerebral hemorrhage patients.
All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.Some ICH patients were evaluated for Stereotactic minimally invasive surgery (sMIS) treatment by two experienced neurosurgeons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APOE-E4 (ε2/ε4,ε3/ε4,ε4/ε4) group | – | Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. |
| APOEε3(ε3/ε3) group | – | Diagnostic Test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)All the patients in this study received the same medications based on the guidelines for the management of hypertensive intracerebral hemorrhage.In addition, all patients received more comprehensive measures to prevent deep vein thrombosis (DVT), control blood pressure and glucose, nutritional support, and prevent other complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This prospective cohort study on spontaneous ICH was conducted at the Affiliated Hospital of Guizhou Medical University from January 2020 to December 2023. The patients were diagnosed with ICH by CT scan and has APOE gene test results. Screening was performed according to the following inclusion criteria, and patients meeting the above criteria were divided into ApoE-ε3 and ApoE-ε4 groups according to APOE test results.
Key inclusion criteria (2 listed)
- Relevant diagnosis of supratentorial ICH was confirmed through unenhanced CT scanning.
- Patients were distinguished based on venous blood collection, with the presence of the ApoE-ε4 (ε2/ε4, ε3/ε4, ε4/ε4) gene (ApoE-ε4 genotype) and patients harboring the ApoE-ε3 (ε3/ε3) gene (non-ApoE-ε4 genotype).
Key exclusion criteria (7 listed)
- Patients with infratentorial ICH.
- Patients with ApoE-ε2 (ε2/ε2) based on venous blood collections.
- Younger than 18 years of age.
- ICH caused by trauma, anticoagulation therapy, or antiplatelet therapy.
- Patients admitted to the hospital with diseases that might impact inflammatory responses, such as infective meningitis and systemic infections.
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 |
|---|---|---|
| Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)Non-surgical patients were followed up by CT on days 1 and 5-7 after ICH, and by CT or MRI on day 5-7. Surgical patients were followed up by CT before surgery and then transferred to the operating room. The first postoperative follow-up CT scan was performed on the second day after surgery, and the second postoperative CT scan was performed on the third day after surgery. Some patients need a third or even a fourth CT follow-up after surgery. The CT scan can be repeated at any time if the patient has neurologic deterioration. | Diagnostic test | APOE-E4 (ε2/ε4,ε3/ε4,ε4/ε4) group, APOEε3(ε3/ε3) group |
Primary outcome
One month after ICH
Time frame: A maximum of 1 month was assessed from the date of randomization to the date of the first record of progression or death from any cause, whichever came first.
Telephone follow-up by experienced neurologist.Defining a modified Rankin Scale (mRS) score of 0-3 at discharge was considered to be a good prognosis. If the mRS score was >3, the prognosis was considered poor.
Volume of perihematoma edema
Time frame: Within 24 hours of ICH
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Changes in the volume of perihematoma edema
Time frame: Days 5-7 after ICH
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
1 secondary outcome
Venous blood indicators
Time frame: Within 24 hours of the onset of ICH
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 9 Aug 2024.
- Derived from this study: PubMed 39956815Huang L, Wu Q, Ye F, Che W, Zhao X, Yang C, Ren S, Wu G, Wang L. Apolipoprotein E-epsilon4 allele is associated with perihematomal brain edema and poor outcomes in patients with intracerebral hemorrhage. Sci Rep. 2025 Feb 16;15(1):5682. doi: 10.1038/s41598-025-89868-3.
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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.
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 Intracerebral Hemorrhage, run by The Affiliated Hospital Of Guizhou 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 2 inclusion and 7 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 9 Aug 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?
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?
One month after ICH (time frame: A maximum of 1 month was assessed from the date of randomization to the date of the first record of progression or death from any cause, whichever came first.). The study lists 3 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 NCT05687201, 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 9 Aug 2024.