Study on the Relationship Between Asymmetric Vascular Sign of Cortex and Prognosis in Massive Cerebral Infarction

January 27, 2020 updated by: liuxiaoyun, The Second Hospital of Hebei Medical University

Study on the Relationship Between Asymmetric Vascular Sign of Cortex and Cerebral Edema and Prognosis of Massive Cerebral Infarction

Susceptibility weighted imaging (SWI) technology has developed in the decade which is being a kind of cerebrovascular disease diagnostic tools in the clinical application, especially for paramagnetic material (such as DNA hemoglobin and hemosiderin) has a high sensitivity.

The change of the signal on SWI bases on the change of local oxygenated hemoglobin content in the blood and deaeration hemoglobin content ratio, which can be used to indirectly reflect the hypoxia group oxygen intake fraction (OEF) and cerebral metabolic rate. When the intracranial vascular occlusion, corresponding responsibility vascular blood flow area of brain tissue will occur hypoperfusion, brain tissue will improve the compensation in accordance with its own OEF, causing ischemia area inside the venous drainage of deaeration hemoglobin content ratio increases and the hypointensity on SWI ,which display the asymmetric cortical vessel sign (ACVS). Studies have suggested that ACVS is more prone to early neurological deterioration and has a poor long-term outcome. After recanalization of ischemic stroke, the presence of equal CVS(return to normal) on SWI is associated with a good clinical outcome. In addition, the relationship between ACVS grade and collateral circulation in patients with acute ischemic stroke has been studied. For patients with massive cerebral infarction, the relationship between ACVS on SWI and the clinical prognosis of cerebral edema and cerebral hemodynamics is not completely clear. In this study, the clinical data of patients with massive cerebral infarction will be analyzed to explore the relationship between ACVS, cerebral edema , cerebral hemodynamic and clinical prognosis.

Sodium aescinate is widely used in cerebral edema caused by cerebral hemorrhage or cerebral infarction.The main mechanism of sodium aescinate is anti - inflammatory, anti - exudate, anti - oxygen free radical, anti - edema, increase vein tension, improve blood circulation and nerve protection. In this study, investigators will investigate whether the application of sodium aescinate had an effect on ACVS on SWI in patients with massive cerebral infarction. Plasma s100-β, procalcitonin, neutrophil count, serum fibronectin, and endothelin-1 could predict cerebral edema in patients with cerebral infarction, this study will analyze the relationship between these markers and ACVS on SWI in patients with massive cerebral infarction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Clinical data and plasma samples of patients diagnosed with massive cerebral infarction in the department of neurology of the second hospital of hebei medical university during 2020.1-2021.6 are collected.Clinical data include gender, age, TOAST classification, history of hypertension, diabetes and heart disease, head Computerized Tomography (CT), Magnetic Resonance Imaging(MRI), Diffusion-Weighted Imaging (DWI),Susceptibility weighted imaging SWI within 72 hours after onset, admission National Institute of Health stroke scale ( NIHSS) score, admission DWI-aspect score, Modified Rankin Scale (MRS) score on day 90 of onset.Venous blood will be taken within 72 hours of onset (and before the use of sodium aescinate) to detect serum s100-β, serum procalcitonin, plasma fibronectin, serum endothelin-1 by ELISA.The cortical vessel signs（CVSs）on SWI in the ischemic territory are classified as 'prominent' if there are more veins and/or larger veins with a greater signal loss than those in the opposite normal hemisphere, 'equal' if there are no significant differences in appearance of veins in the both cerebral hemispheres, and 'less' if the veins in the affected area are decreased compared to those in the normal cortex.

Patients with massive cerebral infarction to be included are randomly divided into experimental group and control group by random number table method.The experimental group is treated with sodium aescinate for injection on the basis of conventional treatment. The control group is not treated with sodium aescinate for injection.

This study will explore the relationship between asymmetric cortical vessel sign(ACVS) grade and baseline clinical data, serum factors associated with brain edema in patients with massive cerebral infarction.In addition,after 10 days of sodium aescinate injection, the CVS level of the experimental group will be compared with that of the control group.The difference of CVS grading before and after injection of sodium aescinate in the experimental group will be compared.Finally,the indexes with significance in single factor analysis will be screened out, and the factors related to prognosis of massive cerebral infarction will be further analyzed by multi-factor logistics regression.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

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
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Second Hospital of Hebei Medical University
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years old
  • Massive cerebral infarction within 72 hours from onset to admission
  • Without other intracranial lesions or severe disease
  • Agrees to participate in the study and sign the informed consent

Exclusion Criteria:

  • Cerebral vascular malformation
  • Cranial trauma and cranial surgery history
  • With severe cardiac, hepatic and renal insufficiency
  • With blood disorder, immune rheumatism (hormone abuse)
  • Expected survival of less than 3 months
  • Refuse to participate in this study

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental group
In the experimental group, sodium aescinate is added on the basis of conventional treatment(such as anti-platelet and improve circulation).The treatment course of sodium aescinate is 10 days,20mg/day.
Drug: sodium aescinate
The main mechanism of sodium aescinate includes anti - inflammatory, anti - exudate anti - oxygen free radical ,anti - edema increased venous tension.The treatment course of sodium aescinate is 10 days,20mg/day, intravenous infusion.
Other Names:
  • Sodium Aescinate for Injection
NO_INTERVENTION: Control group
The control group will receive conventional treatment(anti-platelet and improve circulation) without sodium aescinate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between asymmetric cortical vessel sign(ACVS) and age
Time Frame: 2 hour
To evaluate whether ACVS and age are related
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and sex
Time Frame: 2 hour
To evaluate whether ACVS and sex are related
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and TOAST subtypes
Time Frame: 2 hour
Classification of causes of stroke --TOAST classification include Large-artery atherosclerosis( LAA),Cardioembolism(CE) ,Small-artery occlusion(SAO),Stroke of other determined cause(ODC) and Stroke of undetermined cause(UND).
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and smoking history
Time Frame: 2 hour
To evaluate whether ACVS and smoking history are related
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and NIHSS score at admission
Time Frame: 2 hour
The NIHSS score is 0 to 42 points. The higher the score, the more severe the nerve damage.
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and mRS on 90 day
Time Frame: 2 hour
The mRs score is used to measure the recovery of neurological function in patients after stroke. The mRs score is 0 to 6 points. The higher the score, the worse the neurological function recovery.
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and DWI ASPECT
Time Frame: 2 hour
ASPECT is a scale suitable for evaluating ischemic changes in the supply area of the middle cerebral artery with a total score of 10.A score of 10 indicates no signs of ischemia, while a score of 0 indicates extensive ischemia in the middle cerebral artery
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and midline shift
Time Frame: 2 hour
To evaluate whether ACVS and midline shift are related
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and offending stenosis
Time Frame: 2 hour
To evaluate whether ACVS and offending stenosis are related
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and serum factor S100-B
Time Frame: 2 hour
In acute ischemic stroke, the astroglial protein S100B is released into peripheral blood, reaching maximum serum concentrations between day 2 and day 4, correlating with infarct size.
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and serum factor procalcitonin
Time Frame: 2 hour
Procalcitonin is a stronger predictor of long-term functional outcome and mortality in patients with ischemic stroke.
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and cellular-fibronectin
Time Frame: 2 hour
A high plasma cellular-fibronectin concentration at admission is associated with the development of m-MCA infarction with high sensitivity and specificity.
2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and serum factor endothelin - 1
Time Frame: 2 hour
endothelin - 1 may be a diagnostic marker for development of severe brain edema in patients with acute ischemic stroke.
2 hour
Changes of aescinin on asymmetric cortical vessel sign (ACVS).
Time Frame: 2 hour
This study investigates whether the application of sodium aescinate has an effect on ACVS on SWI in patients with massive cerebral infarction.
2 hour

Collaborators and Investigators

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

Sponsor

The Second Hospital of Hebei 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 9, 2020

Primary Completion (ANTICIPATED)

June 9, 2021

Study Completion (ANTICIPATED)

September 9, 2021

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-P002

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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