NCT03125759

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

9 years

First QC Date

April 1, 2017

Last Update Submit

April 21, 2017

Conditions

Keywords

Ischemic StrokeOmentin

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 3 years

  • 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.

    up to 3 years

Secondary Outcomes (5)

  • the NIHSS assessed for functional outcome of stroke

    up to 3 years

  • the modified Rankin Scale assessed for functional disability

    up to 3 years

  • the Barthel index assessed for functional independence in activities

    up to 3 years

  • the number of all cause death

    up to 3 years

  • the number of re-stroke in case group

    up to 3 years

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi'an No.3 Hospital

Xi’an, Shanxi, 710018, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

StrokeBrain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tian Ye, PhD

    Xi'an No.3 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2017

First Posted

April 24, 2017

Study Start

January 1, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 24, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

Locations