StrokeNCT03125759
The Association of Omentin and Ischemic Stroke
An observational study of Stroke and Brain Ischemia, run by Xi'an No.3 Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke, Brain Ischemia, Adipokines
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: the study population is from primary care clinic, physical examination center, and social volunteers.
Who may be able to join
- For ischemic stroke group,acute clinically defined ischemic stroke
- For control group, without any history of stroke
Who cannot join
- For ischemic stroke group
- Hemorrhagic Stroke
- Previous Ischemic Stroke For control group
- The expected life expense less than 3 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an No.3 Hospital
Xi’an, Shanxi, 710018
Tian Ye, doctor
About this study
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.
- Conditions
- Stroke, Brain Ischemia, Adipokines, Mutation
- Keywords
- Ischemic Stroke, Omentin
- Medical subject headings
- Stroke, Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 3 years
Secondary outcomes (5)
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.
Measured: up to 3 years
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.
Measured: up to 3 years
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.
Measured: up to 3 years
the number of all cause death
The number of all cause of death will be recorded in both groups.
Measured: up to 3 years
the number of re-stroke in case group
Recurrent of stroke will be monitored through out in case group.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tian Ye, PhD, Principal investigator, Xi'an No.3 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125759
- Sponsor's protocol ID
- NDIS001
- Status last verified
- Apr 2017
- First submitted
- 1 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Omentin and Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03125759
- Acronym / sponsor ID
- NDIS001
- Conditions
- Stroke, Brain Ischemia, Adipokines, Mutation
- Keywords
- Ischemic Stroke, Omentin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study population is from primary care clinic, physical examination center, and social volunteers.
Key inclusion criteria (2 listed)
- For ischemic stroke group,acute clinically defined ischemic stroke
- For control group, without any history of stroke
Key exclusion criteria (4 listed)
- For ischemic stroke group
- Hemorrhagic Stroke
- Previous Ischemic Stroke For control group
- The expected life expense less than 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the odds ratio of omentin plasma concentration between cases and controls
Time frame: up to 3 years
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.
the frequency difference of single nucleotide polymorphism(SNP) of omentin in the enrolled subjects
Time frame: up to 3 years
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.
5 secondary outcomes
the NIHSS assessed for functional outcome of stroke
Time frame: up to 3 years
the modified Rankin Scale assessed for functional disability
Time frame: up to 3 years
the Barthel index assessed for functional independence in activities
Time frame: up to 3 years
the number of all cause death
Time frame: up to 3 years
the number of re-stroke in case group
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian Ye, PhD principal investigator
Xi'an No.3 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Brain Ischemia, run by Xi'an No.3 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian Ye, PhD (+86 13519131549, chhty@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the odds ratio of omentin plasma concentration between cases and controls (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.