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Clinical Trials/NCT05687201
NCT05687201
Completed
Not Applicable

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

The Affiliated Hospital Of Guizhou Medical University1 site in 1 country330 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracerebral Hemorrhage
Sponsor
The Affiliated Hospital Of Guizhou Medical University
Enrollment
330
Locations
1
Primary Endpoint
One month after ICH
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
The Affiliated Hospital Of Guizhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Lei Huang

Principal Investigator

The Affiliated Hospital Of Guizhou Medical University

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Venous blood indicators(Within 24 hours of the onset of ICH)

Study Sites (1)

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