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RecruitingNCT03125759Updated Apr 24, 2017

The Association of Omentin and Ischemic Stroke

An observational study in Stroke, Brain Ischemia and Adipokines, sponsored by Xi'an No.3 Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Xi'an No.3 Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study summary

This observational study aims to research whether there is a relationship between omentin and ischemic stroke on the aspects of incidence, severity, and recovery etc.

Read the detailed description

To study the possible relationship between omentin and ischemic stroke, we intend to recruit the newly found acute ischemic stroke patients and patients without any stroke history and analysis the difference of plasma omentin level and the ITLN, which is the gene symbol of omentin.

02

Conditions studied

  • Stroke
  • Brain Ischemia
  • Adipokines
  • Mutation

Keywords

  • Ischemic Stroke
  • Omentin
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

the study population is from primary care clinic, physical examination center, and social volunteers.

Inclusion criteria

  • For ischemic stroke group,acute clinically defined ischemic stroke
  • For control group, without any history of stroke

Exclusion criteria

Exclusion Criteria:

For ischemic stroke group

  • Hemorrhagic Stroke
  • Previous Ischemic Stroke For control group
  • The expected life expense less than 3 years
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control

    patients without any history of stroke

  • Ischemic Stroke

    patients with an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction within 72 hours.

05

What researchers measure

Primary outcomes

  1. the odds ratio of omentin plasma concentration between cases and controls

    The circulation level of omentin will be assessed in cases and controls. Then the odds ratio will be statically analysed to detect whether omentin is asociated with ischemic stroke on protein level.

    Time frame: up to 3 years

  2. the frequency difference of single nucleotide polymorphism(SNP) of omentin in the enrolled subjects

    The SNP will be analysed in the recruited subjects. And the the frequency difference will be calculated to explore if any SNP is related to ischemic stroke.

    Time frame: up to 3 years

Secondary outcomes

  1. the NIHSS assessed for functional outcome of stroke

    NIHSS wil be used to assess neurological status at baseline or the point of stroke, the point of out-patient, 3 month, 6 month, 1 year, 2 year and the 3 year.

    Time frame: up to 3 years

  2. the modified Rankin Scale assessed for functional disability

    Th functional disability will be assessed using the modified Rankin Scale at the time of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment.

    Time frame: up to 3 years

  3. the Barthel index assessed for functional independence in activities

    The Barthel index at the point of baseline, out-patient, 3rd month, 6th month, 1st year, 2nd year and the 3rd year after enrollment will be assessed for the functional independence in activities.

    Time frame: up to 3 years

  4. the number of all cause death

    The number of all cause of death will be recorded in both groups.

    Time frame: up to 3 years

  5. the number of re-stroke in case group

    Recurrent of stroke will be monitored through out in case group.

    Time frame: up to 3 years

06

Study locations

1 of 1 sites recruiting
  • Xi'an No.3 Hospital
    Xi'an, Shanxi 710018, China
    • Tian Ye, doctor · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03125759
Lead sponsor
Xi'an No.3 Hospital
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Jan 1, 2017
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 24, 2017

Study contacts

Tian Ye, PhD
Contact
chhty@sina.com
+86 13519131549
Tian Ye, PhD
principal investigator · Xi'an No.3 Hospital
View the source record on ClinicalTrials.gov ↗

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