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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03125759
Other study ID # NDIS001
Secondary ID
Status Recruiting
Phase N/A
First received April 1, 2017
Last updated April 21, 2017
Start date January 1, 2017
Est. completion date December 31, 2025

Study information

Verified date April 2017
Source Xi'an No.3 Hospital
Contact Tian Ye, PhD
Phone +86 13519131549
Email chhty@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- For ischemic stroke group,acute clinically defined ischemic stroke

- For control group, without any history of stroke

Exclusion Criteria:

For ischemic stroke group

- Hemorrhagic Stroke

- Previous Ischemic Stroke For control group

- The expected life expense less than 3 years

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xi'an No.3 Hospital Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Xi'an No.3 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. up to 3 years
Secondary 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. up to 3 years
Secondary 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. up to 3 years
Secondary the number of all cause death The number of all cause of death will be recorded in both groups. up to 3 years
Secondary the number of re-stroke in case group Recurrent of stroke will be monitored through out in case group. up to 3 years
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