Serum Neuroglobin and HIF-1α in Acute Ischemic Stroke

Sponsor
Shanghai 6th People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02297984
Collaborator
(none)
40
1
12
3.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Changes of Serum Neuroglobin and HIF-1α Concentrations in Early-phase of Acute Ischemic Stroke
    Study Start Date :
    Oct 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Oct 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Acute ischemic stroke

    Patients who suffered from acute ischemic stroke within 12 hours for the first time before entry into the study.

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rankin Scale scores [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 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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    42 Years to 76 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Sixth People's Hospital Shanghai China 200233

    Sponsors and Collaborators

    • Shanghai 6th People's Hospital

    Investigators

    • Study Director: Lixia Xue, M.D., Ph.D., Shanghai 6th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hao Chen, Doctor, Shanghai 6th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02297984
    Other Study ID Numbers:
    • H1583-660145
    First Posted:
    Nov 21, 2014
    Last Update Posted:
    Aug 11, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Hao Chen, Doctor, Shanghai 6th People's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2020