NCT02297984

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

November 19, 2014

Last Update Submit

August 8, 2020

Conditions

Keywords

NeuroglobinHIF-αAcute ischemic strokePrognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Glasgow Outcome Scale scores

    3 months

Study Arms (1)

Acute ischemic stroke

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

Eligibility Criteria

Age42 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • Clinical diagnosis of acute ischemic stroke
  • Admission within 12 hours

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lixia Xue, M.D., Ph.D.

    Shanghai 6th People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 21, 2014

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations