Long-Term Survival After Ischaemic Stroke: Ebrictus Study (EBRICTUS)

April 3, 2022 updated by: Josep Lluís Clua Espuny, Jordi Gol i Gurina Foundation

Long Survival After Ischemic Stroke and Thombolysis in Catalonia. Differences by Sex

A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. The authors sought to examine the relationship between sex and outcome after thrombolysis.

Previous reports [1-6] concerning sex-related differences in stroke management and outcome are inconsistent and sometimes difficult to interpret, and so the reasons for gender disparities in stroke outcome have remained unclear. Functional outcomes and quality of life after stroke are consistently poorer in women despite adjustment for baseline differences in age and prestroke function, and the fact that comorbidities and clinical outcomes were not different between women and men [3, 7] . Once the reasons for these differences are better understood, intervention might be possible to help provide the best care for all patients. This work is a continuation and extension of the Ebrictus Study [8-10] . Prior work has suggested sex-based differences in thrombolytic therapy in subjects with acute stroke [11] .The authors will explore whether sex might modify the effect of thrombolysis on survival and functional outcomes in patients with acute ischemic stroke [12] beyond the usually evaluated time period of 6 months after stroke and compared this with the group without thrombolytic treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a reprospective, observational cohort study including incident strokes from January 1, 2011 to December 31, 2012 and followed up in December 31, 2016. Statistical approaches are used to analyze survival outcomes. It is a longitudinal study of a population-based cohort of all registered cases of a first episode of stroke that occurred in Catalonia (Spain). Demographic Patterns and Epidemic Characteristics. Life expectancy at birth is 81.34 years globally, 78.26 years for men and 84.74 years for women.

Case Definition The definition of stroke corresponds to that set by the World Health Organization.

Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).

The inclusion criteria were: age ≥ 15 up to ≤ 90; a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b) hospital clinic, or (c) access to medical/sociosanitary reports.

The variables on which information was collected were grouped as follows: sociodemographic; clinics: type (ischemic or hemorrhagic stroke) and event date (day/month/year); NIHSS score on admission; whether or not there was thrombolytic therapy; duration of hospital stay; hospital discharge destination (home, higher-level acute hospital, long-term care hospital, death and date thereof); pre- and poststroke functional autonomy [the Barthel score was classified as follows: <20 (total dependence), 20-35 (severe dependence), 40-55 (moderate dependence), ≥ 60 (mild dependence), or 100 (independence) registered for preepisode and for discharge in the medical history of the patient, the hospital, or the primary care center]; functional status of the patient at discharge: death, home-autonomous, home address caregiver, referral to another acute hospital, or convalescent center (temporary or long-term stay), and vital status (alive/dead) of the patient, specifying the date (day/month/year) of death, if any.

Statistical Analysis Computerized statistical analysis was undertaken with the following: (1) descriptive basic statistics and standard deviation of key variables stratified by age and sex and (2) differences in functional outcome and its evolution before and after the episode determined the possible effects on mortality and different residual deficits categorized with the statistical Cox regression model. Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.

Study Type

Observational

Enrollment (Actual)

21000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08005
        • Plan Director Enfermedad Vascular Cerebral

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

15 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were included by using the automated operation of the database of patients with a diagnosis code of stroke (I60-I69).

Description

Inclusion Criteria:

  • age ≥ 15 up to ≤ 90;
  • usual residence in Catalonia
  • and/or assignment to any of the catalonian primary care centers for 5 years at the time of the stroke episode;
  • a diagnosis of stroke explicitly recorded in their medical record at any of the registration systems in the health centers of the area; it should be a first stroke episode, and relevant episode information should be available in clinical records: (a) outpatient clinic, (b)hospital clinic, or (c) access to medical/sociosanitary reports.

Exclusion Criteria:

  • intracerebral haemorrhage

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death all causes
Time Frame: January 1, 2011 to December 31, 2016
Mortality should be interpreted as overall mortality and cause-specific, no stroke. Patients who died during hospitalization or within the 1st month are considered 'immediate death'. During follow-up the deceased are described as 'subsequent mortality'.
January 1, 2011 to December 31, 2016

Collaborators and Investigators

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

Sponsor

Jordi Gol i Gurina Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 13, 2017

Primary Completion (ACTUAL)

July 30, 2017

Study Completion (ACTUAL)

August 5, 2017

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (ACTUAL)

August 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R17/017
  • 17/034 Codi IDIAP: 4R17/017 (OTHER_GRANT: SIDIAP 16/9)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Dates files

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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