NCT02157896

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 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

May 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

June 4, 2014

Last Update Submit

August 8, 2020

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic strokeVascular endothelial growth factorEndostatin

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 \- 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.

    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, and had a score between 6 and 25 on the National Institutes of Health Stroke Scale (NIHSS).

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

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
  • Died within the first week of hospitalization
  • 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples

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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

May 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

CN(1)