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

NCT04247659 | Unknown Phase 4

• 1 other identifier: 2020-P002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Infarction; Cerebral Edema

Keywords

massive cerebral infarction; asymmetric vascular sign of cortex; Sodium aescinate

Outcome Measures

Primary Outcomes (14)

• The correlation between asymmetric cortical vessel sign(ACVS) and age

  To evaluate whether ACVS and age are related

  2 hour

• The correlation between asymmetric cortical vessel sign(ACVS) and sex

  To evaluate whether ACVS and sex are related

  2 hour

• The correlation between asymmetric cortical vessel sign(ACVS) and TOAST subtypes

  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

  To evaluate whether ACVS and smoking history are related

  2 hour

• The correlation between asymmetric cortical vessel sign(ACVS) and NIHSS score at admission

  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

  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

  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

  To evaluate whether ACVS and midline shift are related

  2 hour

• The correlation between asymmetric cortical vessel sign(ACVS) and offending stenosis

  To evaluate whether ACVS and offending stenosis are related

  2 hour

• The correlation between asymmetric cortical vessel sign(ACVS) and serum factor S100-B

  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

  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

  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

  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).

  This study investigates whether the application of sodium aescinate has an effect on ACVS on SWI in patients with massive cerebral infarction.

  2 hour

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will receive conventional treatment(anti-platelet and improve circulation) without sodium aescinate.

Interventions

sodium aescinate DRUG

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.

Also known as: Sodium Aescinate for Injection

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

Second hospital of hebei medical university

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction; Brain Edema

Interventions

sodium aescinate; Injections

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xiaoyun Liu, Prf.

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junzhao Cui, Dr

CONTACT

+8615032189957; 1097709288@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of neurology

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 30, 2020
• Study Start: January 9, 2020
• Primary Completion: June 9, 2021
• Study Completion: September 9, 2021
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

CN (1)