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Effect of Apolipoprotein E on the Prognosis of Patients With Intracerebral Hemorrhage

Effect of Apolipoprotein E4 on Perihematomal Edema and Short-term Prognosis in Patients With Intracerebral Hemorrhage

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05687201
Enrollment
330
Registered
2023-01-18
Start date
2020-01-01
Completion date
2023-12-01
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage, Apolipoprotein E gene, Perihematomal edema, Outcome

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.

Interventions

DIAGNOSTIC_TESTNon-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.

Sponsors

The Affiliated Hospital Of Guizhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
One month after ICHA 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 edemaWithin 24 hours of ICHCalculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Changes in the volume of perihematoma edemaDays 5-7 after ICHCalculation of perihematoma edema volume after ICH by non-enhanced CT scan.

Secondary

MeasureTime frameDescription
Venous blood indicatorsWithin 24 hours of the onset of ICHIndicators of venous blood leukocytes, neutrophils and blood lymphocytes (10\^9/L) were analysed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026