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

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 Overview

• Status: Completed
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Diagnostic test: Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)

• Study Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • Computed Tomography

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.
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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Within 24 hours of ICH
Changes in the volume of perihematoma edema	Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.	Days 5-7 after ICH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous blood indicators	Indicators of venous blood leukocytes, neutrophils and blood lymphocytes (10^9/L) were analysed.	Within 24 hours of the onset of ICH

Collaborators and Investigators

• Sponsor: The Affiliated Hospital Of Guizhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Outcome; Intracerebral Hemorrhage; Perihematomal edema; Apolipoprotein E gene
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: HL970570

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No