Obesity Effect on Stroke and Cardiovascular Events (OSR)

August 26, 2019 updated by: Prof. Dr. Emre Kumral, Ege University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

9285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All stroke patients enrolled in the prospective cohort registry in Egeanregion.

Description

Inclusion Criteria:

  • All consecutive stroke patients.

Exclusion Criteria:

  • Incomplete baseline information, other factors making them unsuitable for follow-up,undetermined stroke, subarachnoid hemorrhage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with obesity
Obesity in those with BMI ≥30 kg/m2
Diagnostic test: Obesity assessment
Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height
Patients without obesity
Normal weight was considered in the patients with BMI <30 kg/m2
Diagnostic test: Obesity assessment
Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke recurrence
Time Frame: 5 years
Ischemic or hemorrhagic stroke
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2000

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If the publisher will accept to share IPD, we can give permission to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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