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

NCT05687201 | Completed

• 1 other identifier: HL970570
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Apolipoprotein E gene; Perihematomal edema; Outcome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Venous blood indicators

  Within 24 hours of the onset of ICH

Study Arms (2)

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)

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)

Interventions

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.

APOE-E4 (ε2/ε4,ε3/ε4,ε4/ε4) group; APOEε3(ε3/ε3) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

Study Sites (1)

Computed Tomography

Guiyang, Guizhou, 550001, China

Location

Related Publications (1)

• 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.

  PMID: 39956815 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 18, 2023
• Study Start: January 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)