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

NCT ID: NCT05687201

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)

Intervention Type: 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.

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.

Non-enhanced CT scan、Nuclear Magnetic Resonance (MRI)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Lei Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Computed Tomography

Guiyang, Guizhou, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39956815 (View on PubMed)

Other Identifiers

HL970570

Identifier Type: -

Identifier Source: org_study_id