Long-Term Survival After Ischaemic Stroke: Ebrictus Study

NCT03247036 | Completed DMC

• 2 other identifiers: 4R17/01717/034 Codi IDIAP: 4R17/017
• Study Type: observational
• Target: 21,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke; Thrombolytic (t-PA) Treatment; Gender Bias; Long Term Adverse Effects

Outcome Measures

Primary Outcomes (1)

• Death all causes

  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

Interventions

IV thrombolytic (t-PA) treatment vs not DRUG

Acute Stroke Protocol

Also known as: IV thrombolysis, IV thrombolytic (t-PA) treatment

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• intracerebral haemorrhage

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Plan Director Enfermedad Vascular Cerebral

Barcelona, 08005, Spain

Location

Related Publications (5)

• Clua-Espuny JL, Ripolles-Vicente R, Forcadell-Arenas T, Gil-Guillen VF, Queralt-Tomas ML, Gonzalez-Henares MA, Panisello-Tafalla A, Lopez-Pablo C, Lucas-Noll J; Ebrictus Group. Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study. Cerebrovasc Dis Extra. 2015 Oct 9;5(3):95-102. doi: 10.1159/000440734. eCollection 2015 Sep-Dec.

  PMID: 26648964 BACKGROUND

• Clua-Espuny JL, Ripolles-Vicente R, Lopez-Pablo C, Panisello-Tafalla A, Lucas-Noll J, Calduch-Noll C, Gonzalez-Henares MA, Queralt-Tomas ML. [Differences in the survival after an episode of stroke treated with thrombolytic therapy. Study Ebrictus]. Aten Primaria. 2015 Feb;47(2):108-16. doi: 10.1016/j.aprim.2014.04.008. Epub 2014 Jun 19. Spanish.

  PMID: 24953174 BACKGROUND

• Gonzalez-Henares A, Clua-Espuny JL, Gil-Guillen VF, Panisello-Tafalla A, Queralt-Tomas ML, Ripolles-Vicente R, Lopez-Pablo C, Lucas-Noll J, Equipo de Investigacion Ebrictus Ede I. [Incidence and preventability of haemorrhagic strokes. Results of the Ebrictus register]. Rev Neurol. 2016 May 1;62(9):385-95. Spanish.

  PMID: 27113062 BACKGROUND

• Clua-Espuny JL, Abilleira S, Queralt-Tomas L, Gonzalez-Henares A, Gil-Guillen V, Muria-Subirats E, Ballesta-Ors J. Long-Term Survival After Stroke According to Reperfusion Therapy, Cardiovascular Therapy and Gender. Cardiol Res. 2019 Apr;10(2):89-97. doi: 10.14740/cr839. Epub 2019 Apr 11.

  PMID: 31019638 RESULT

• Clua-Espuny JL, Pinol-Moreso JL, Gil-Guillen FV, Orozco-Beltran D, Panisello-Tafalla A, Lucas-Noll J. [The stroke care system in Terres de l'Ebre, Spain, after the implementation of the Stroke Code model: Ebrictus Study]. Med Clin (Barc). 2012 May 19;138(14):609-11. doi: 10.1016/j.medcli.2011.10.004. Epub 2011 Dec 6. Spanish.

  PMID: 22153783 RESULT

MeSH Terms

Conditions

Ischemic Stroke; Sexism; Long Term Adverse Effects

Interventions

Fibrinolytic Agents; Therapeutics

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Prejudice; Social Behavior; Behavior; Social Discrimination; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Family and Community Medicine

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: January 13, 2017
• Primary Completion: July 30, 2017
• Study Completion: August 5, 2017
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)