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Vascular Endothelial Growth Factor and Endostatin in Angiogenesis After Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT02157896
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Shanghai 6th People's Hospital

Brief Summary:
Vascular endothelial growth factor (VEGF) and Endostatin (ES) participate angiogenesis after cerebral ischemia. Circulating endothelial progenitor cells (EPCs) also play a crucial role in neovascularization and tissue repair after acute ischemic stroke (AIS). The investigators sought to compare the expression of VEGF and ES in serum and the circulating EPCs in patients after AIS with that of healthy control subjects. The investigators obtained peripheral blood and serum samples from study subjects. EPCs in blood samples from AIS patients and healthy controls were quantified by flow cytometry 1 day, 3 days, 5 days and 7 days after AIS. VEGF and ES were measured by enzyme linked immunosorbent assay at the same time points. The relation between them and the relation of them to prognosis of such patients with acute ischemic stroke were assessed.

Condition or disease
Acute Ischemic Stroke

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dynamic Changes of Vascular Endothelial Growth Factor and Endostatin in Association With Circulating Endothelial Progenitor Cells After Acute Ischemic Stroke
Study Start Date : May 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Group/Cohort
Acute ischemic stroke
Patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study, and had a score between 6 and 25 on the National Institutes of Health Stroke Scale (NIHSS).



Primary Outcome Measures :
  1. Modified Rankin Scale scores [ Time Frame: 3 months ]

    0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate

    - Page 3 of 4 [DRAFT] - disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead.



Secondary Outcome Measures :
  1. Glasgow Outcome Scale scores [ Time Frame: 3 months ]
    Glasgow Outcome Scale 1 = death; Glasgow Outcome Scale 2 = vegetative state; Glasgow Outcome Scale 3 = severe neurological deficit; Glasgow Outcome Scale 4 = mild neurological deficit and Glasgow Outcome Scale 5 = premorbid level of functioning or completely recovery.


Biospecimen Retention:   Samples Without DNA
Peripheral blood samples


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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patient group comprised twenty male and ten female. Their age ranged from 45 to 74 years. Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (9 cases), the posterior cerebral artery (8 cases) the anterior cerebral artery (6 cases), vertebrobasilar area (5 cases), and watershed area (2 cases with cortical and subcortical low densities crossing typical vascular territories).
Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute ischemic stroke
  • Admission within 12 hours
  • National Institutes of Health Stroke Scale score 6-25

Exclusion Criteria:

  • Lacunar infarction
  • Cerebral hemorrhagic infarction
  • Epilepsy or epileptic persons
  • History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
  • Contraindications to antiplatelet treatments
  • Died within the first week of hospitalization
  • Serial blood samples could not be obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157896


Sponsors and Collaborators
Shanghai 6th People's Hospital
Investigators
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Principal Investigator: Hao Chen, Ph.D. Shanghai 6th People's Hospital

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Responsible Party: Hao Chen, Doctor, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02157896     History of Changes
Other Study ID Numbers: H1583-660110
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Keywords provided by Hao Chen, Shanghai 6th People's Hospital:
Acute ischemic stroke
Vascular endothelial growth factor
Endostatin
Additional relevant MeSH terms:
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Stroke
Pathologic Processes
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Endostatins
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors