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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02297984
Other study ID # H1583-660145
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date October 2014

Study information

Verified date August 2020
Source Shanghai 6th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender All
Age group 42 Years to 76 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shanghai Sixth People's Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Rankin Scale scores 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. 3 months
Secondary Glasgow Outcome Scale scores 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. 3 months
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