Cerebral InfarctionPhase 4NCT04247659
Study on the Relationship Between Asymmetric Vascular Sign of Cortex and Prognosis in Massive Cerebral Infarction
A Phase 4 study testing sodium aescinate in people with Cerebral Infarction and Cerebral Edema, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Infarction, Cerebral Edema
- What is being tested?
- sodium aescinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2020to 9 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second hospital of hebei medical university
Shijiazhuang, Hebei, 050000
Xiaoyun Liu, Prf., +8613191887318, audrey-l@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Infarction, Cerebral Edema
- Being tested
- sodium aescinate
- Keywords
- massive cerebral infarction, asymmetric vascular sign of cortex, Sodium aescinate
- Medical subject headings
- Cerebral Infarction, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium aescinateDrug
Also called Sodium Aescinate for Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sodium aescinate |
| Control group | No intervention | The control group will receive conventional treatment(anti-platelet and improve circulation) without sodium aescinate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between asymmetric cortical vessel sign(ACVS) and age
To evaluate whether ACVS and age are related
Measured: 2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and sex
To evaluate whether ACVS and sex are related
Measured: 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).
Measured: 2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and smoking history
To evaluate whether ACVS and smoking history are related
Measured: 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.
Measured: 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.
Measured: 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
Measured: 2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and midline shift
To evaluate whether ACVS and midline shift are related
Measured: 2 hour
The correlation between asymmetric cortical vessel sign(ACVS) and offending stenosis
To evaluate whether ACVS and offending stenosis are related
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start9 Jan 2020
- Primary completion9 Jun 2021 (estimated)
- Study completion9 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liuxiaoyun, The Second Hospital of Hebei Medical University
- Investigators
- Xiaoyun Liu, Prf., Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247659
- Sponsor's protocol ID
- 2020-P002
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Asymmetric Vascular Sign of Cortex and Cerebral Edema and Prognosis of Massive Cerebral Infarction
- ClinicalTrials.gov ID
- NCT04247659
- Acronym / sponsor ID
- 2020-P002
- Conditions
- Cerebral Infarction, Cerebral Edema
- Keywords
- massive cerebral infarction, asymmetric vascular sign of cortex, Sodium aescinate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Jun 2021 (estimated)
- Study completion
- 9 Sep 2021 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: sodium aescinateIn 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. |
| Control group | No intervention | –The control group will receive conventional treatment(anti-platelet and improve circulation) without sodium aescinate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium aescinateAlso: Sodium Aescinate for InjectionThe 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. | Drug | Experimental group |
Primary outcome
The correlation between asymmetric cortical vessel sign(ACVS) and age
Time frame: 2 hour
To evaluate whether ACVS and age are related
The correlation between asymmetric cortical vessel sign(ACVS) and sex
Time frame: 2 hour
To evaluate whether ACVS and sex are related
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).
The correlation between asymmetric cortical vessel sign(ACVS) and smoking history
Time frame: 2 hour
To evaluate whether ACVS and smoking history are related
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.
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.
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
The correlation between asymmetric cortical vessel sign(ACVS) and midline shift
Time frame: 2 hour
To evaluate whether ACVS and midline shift are related
The correlation between asymmetric cortical vessel sign(ACVS) and offending stenosis
Time frame: 2 hour
To evaluate whether ACVS and offending stenosis are related
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyun Liu, Prf. principal investigator
The Second Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium aescinate in people with Cerebral Infarction and Cerebral Edema, run by The Second Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junzhao Cui, Dr (+8615032189957, 1097709288@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between asymmetric cortical vessel sign(ACVS) and age (time frame: 2 hour). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.