- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02297984
Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke
August 8, 2020 updated by: Hao Chen, Shanghai 6th People's Hospital
Changes of Serum Neuroglobin and HIF-1α Concentrations in Early-phase of Acute Ischemic Stroke
Neuroglobin has shown rich neuroprotective effects against cerebral ischemia and hypoxia, and therefore has the potential to impact outcomes after acute ischemic stroke.
Hypoxia inducible factor (HIF)-1α is neuroprotective in several models of experimental brain injury and is increased in brain after acute cerebral infarction in humans and experimental animals.The investigators sought to examine the changes in serum neuroglobin and HIF-1α concentrations in patients with acute ischemic stroke during the initial 96-h period after stroke and assessed the relation between them and the relation of them to prognosis of such patients with acute ischemic stroke.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
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
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Shanghai, China, 200233
- Shanghai Sixth People's Hospital
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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
42 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patient group comprised 24 male and 16 female.
Their age ranged from 42 to 76 years.
Locations of infarct, as evidenced by radiologic and neurologic symptoms or signs, included the territories of the middle cerebral artery (13 cases), the posterior cerebral artery (9 cases) the anterior cerebral artery (8 cases), vertebrobasilar area (7 cases), and watershed area (3 cases with cortical and subcortical low densities crossing typical vascular territories).
Description
Inclusion Criteria:
- Clinical diagnosis of acute ischemic stroke
- Admission within 12 hours
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
- Serial blood samples could not be obtained
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
Cohorts and Interventions
Group / Cohort |
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Acute ischemic stroke
Patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Modified Rankin Scale scores
Time Frame: 3 months
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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 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.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Glasgow Outcome Scale scores
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lixia Xue, M.D., Ph.D., Shanghai 6th People's Hospital
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
October 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimate)
November 21, 2014
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 8, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1583-660145
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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