Clinical trial NCT05687201: Effect of Apolipoprotein E on the Prognosis of Patients With Intracerebral Hemorrhage
Official title: Effect of Apolipoprotein E4 on Perihematomal Edema and Short-term Prognosis in Patients With Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Apolipoprotein E gene
Perihematomal edema
Outcome
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: One month after ICH
timeFrame: 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.
measure: Volume of perihematoma edema
timeFrame: Within 24 hours of ICH
measure: Changes in the volume of perihematoma edema
timeFrame: Days 5-7 after ICH
Secondary outcomes:
measure: Venous blood indicators
timeFrame: Within 24 hours of the onset of ICH
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Computed Tomography
state: Guizhou
Study officials:
References: