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NCT Number: NCT05687201

Effect of Apolipoprotein E on the Prognosis of 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Computed Tomography

Guiyang, Guizhou, 550001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Volume of perihematoma edema

    Time frame: Within 24 hours of ICH

    Calculation of perihematoma edema volume after ICH by non-enhanced CT scan.

  3. 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

  1. Venous blood indicators

    Time frame: Within 24 hours of the onset of ICH

    Indicators of venous blood leukocytes, neutrophils and blood lymphocytes (10^9/L) were analysed.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital Of Guizhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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