Stroke, AcuteOSRNCT04062643
Obesity Effect on Stroke and Cardiovascular Events
An observational study of Stroke, Acute, run by Ege University.
Trial summary
The relation between obesity and stroke recurrence is still under debate. In this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Obesity assessment
- How many people
- 9,285 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to Dec 2016
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All stroke patients enrolled in the prospective cohort registry in Egeanregion.
Who may be able to join
- All consecutive stroke patients.
Who cannot join
- Incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.
About this study
Official title: OBESITY ASSOCIATION WITH RECURRENT STROKE AND CARDIOVASCULAR EVENTS
The relation between obesity and stroke recurrence is still under debate. In this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period.
Read the detailed description
Five-years follow-up data of Ege Stroke Registry for stroke recurrence and cardiovascular events regarding to obesity were analyzed. Data include age, gender, stroke severity, neuroimaging studies, cardiovascular risk factors. Within the inclusion period, all of the included patients were followed until censoring (10th of December 2011) or readmission because of recurrent stroke, cardiovascular event or death, whichever came first. The Kaplan-Meier method was used for survival analysis. Cox proportional hazard model was applied to identify predictors of recurrent vascular events.
- Conditions
- Stroke, Acute
- Being tested
- Obesity assessment
- Keywords
- obesity, recurrent stroke, ischemic stroke, hemorrhagic stroke, cardiovascular events, vascular death
- Medical subject headings
- Stroke, Obesity, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obesity assessmentDiagnostic test
Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height
| Study group | Role | What they receive |
|---|---|---|
| Patients with obesity | Obesity in those with BMI ≥30 kg/m2 Receives: Diagnostic Test: Obesity assessment | |
| Patients without obesity | Normal weight was considered in the patients with BMI <30 kg/m2 Receives: Diagnostic Test: Obesity assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke recurrence
Ischemic or hemorrhagic stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study startApr 2000
- Primary completionDec 2011
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 9,285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Emre Kumral, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062643
- Sponsor's protocol ID
- 2010/101
- Acronym
- OSR
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the publisher will accept to share IPD, we can give permission to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBESITY ASSOCIATION WITH RECURRENT STROKE AND CARDIOVASCULAR EVENTS
- ClinicalTrials.gov ID
- NCT04062643
- Acronym / sponsor ID
- OSR / 2010/101
- Conditions
- Stroke, Acute
- Keywords
- obesity, recurrent stroke, ischemic stroke, hemorrhagic stroke, cardiovascular events, vascular death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,285 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Apr 2000 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Aug 2019 (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.
The relation between obesity and stroke recurrence is still under debate. In this study it has been sought whether baseline obesity is associated with recurrent stroke and major cardiovascular events in a long-time period.
Detailed description
Five-years follow-up data of Ege Stroke Registry for stroke recurrence and cardiovascular events regarding to obesity were analyzed. Data include age, gender, stroke severity, neuroimaging studies, cardiovascular risk factors. Within the inclusion period, all of the included patients were followed until censoring (10th of December 2011) or readmission because of recurrent stroke, cardiovascular event or death, whichever came first. The Kaplan-Meier method was used for survival analysis. Cox proportional hazard model was applied to identify predictors of recurrent vascular events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with obesity | – | Diagnostic Test: Obesity assessmentObesity in those with BMI ≥30 kg/m2 |
| Patients without obesity | – | Diagnostic Test: Obesity assessmentNormal weight was considered in the patients with BMI <30 kg/m2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All stroke patients enrolled in the prospective cohort registry in Egeanregion.
Key inclusion criteria (1 listed)
- All consecutive stroke patients.
Key exclusion criteria (1 listed)
- Incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obesity assessmentBody mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height | Diagnostic test | Patients with obesity, Patients without obesity |
Primary outcome
Stroke recurrence
Time frame: 5 years
Ischemic or hemorrhagic stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No. If the publisher will accept to share IPD, we can give permission to share IPD.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Ege University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke recurrence (time frame: 5 years). 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 28 Aug 2019.