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

January 6, 2023 updated by: Zhaoxu，MD, The Affiliated Hospital Of Guizhou Medical University

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We retrospectively collected data from medical records of ICH patients treated between January 1, 2020 and June 1, 2022 at Afliated Hospital of Guizhou Medical University. 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:

  • Diagnosis of ICH confirmed by non-enhanced CT scan.
  • ICH volume less than 85ml.
  • The apolipoprotein genotypes of the patients were APOE-ε3 and APOE-ε4 by venous blood sampling.

Exclusion Criteria:

  • Patients with ICH due to trauma, anticoagulation therapy, or antiplatelet therapy were excluded.
  • The patients with ICH volume greater than 85 ml were excluded.
  • Admission with diseases that may affect the inflammatory response, such as: infectious meningitis, systemic infections, etc.
  • Stroke patients with previous residual neurological deficits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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, 3, and 5 after ICH, and by CT or MRI on day 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, 3, and 5 after ICH, and by CT or MRI on day 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
Volume of perihematoma edema
Time Frame: Days 1 after ICH
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Days 1 after ICH
Changes in the volume of perihematoma edema
Time Frame: Days 3 after ICH
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Days 3 after ICH
Changes in the volume of perihematoma edema
Time Frame: Days 7 after ICH
Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.
Days 7 after ICH
Discharge and 90 days Modified Rankin Scale (mRS) score
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 months.
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.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous blood biochemical parameter
Time Frame: Within 24h of the onset of ICH
Neutrophil test in venous blood drawn within 24 hours of the onset of ICH (neutrophil levels in ×10^9/L)
Within 24h of the onset of ICH
Venous blood biochemical parameter
Time Frame: Within 24h of the onset of ICH
Lymphocyte test in venous blood drawn within 24 hours of the onset of ICH (lymphocyte levels in ×10^9/L)
Within 24h of the onset of ICH
Venous blood biochemical parameter
Time Frame: Within 24h of the onset of ICH
Platelet test in venous blood drawn within 24 hours of the onset of ICH (platelet levels in ×10^9/L)
Within 24h of the onset of ICH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital Of Guizhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Anticipated)

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)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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