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Clinical Trials/NCT02968329
NCT02968329
Completed
Not Applicable

Left Atrial Function as Predictor of Recurrent Stroke or Paroxysmal Atrial Fibrillation in Patients With Cryptogenic Stroke

Hasselt University1 site in 1 country500 target enrollmentOctober 2016
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Hasselt University
Enrollment
500
Locations
1
Primary Endpoint
Recurrent ischemic CVA or TIA
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Stroke is an important cause of disability and the third leading cause of death.

Approximately 30 to 40 % of all strokes are estimated to be cryptogenic (i.e. no cause can be found). There have been few previous studies regarding risk stratification for stroke recurrence in patients with cryptogenic stroke.

Recent studies have suggested that left atrial (LA) function is an important determinant of stroke risk. However, most studies focus on volume indices and LA dimensions, we also want to investigate other echocardiographic parameters. The aim of this study is to assess the predictive value of left atrial function for the risk of stroke recurrence and/or atrial fibrillation by transthoracic echocardiography in cryptogenic stroke patients with no proven atrial fibrillation (AF) and no indication for anticoagulants.

Detailed Description

Study design and population The investigators used a retrospective mono-centric case-control design and analyzed all patients admitted for cerebrovascular accident (CVA) or transient ischemic attack (TIA) between 2011 and 2014. The investigators searched for patients who had a recurrent CVA/TIA and/or who were diagnosed with newly documented AF during the study duration. Clinical, demographic and laboratory parameters were assessed. Echocardiographic parameters, measured on first admission, were analyzed using EchoPAC version 112. Statistical analysis Univariate analysis was performed for all covariates using the Cox proportional hazards model. Likelihood ratio tests were used to determine significance for all parameters. If covariates were significant at the 25% significance level, they were used in the multivariate model. Multivariate analysis was performed using the Cox proportional hazards model with backward elimination model selection. The Wald Chi-Square test was used to determine significance at 5% significance level. The program used for analysis is SAS version 9.4.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
April 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

prof. dr. Paul Dendale

prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • proven AF or atrial flutter
  • prior ablation for AF
  • valvular disease
  • artificial heart valves
  • endocarditis
  • presence of an atrial septum defect or moderate to large patent foramen ovale
  • LV akinesia
  • moderate to severe carotid stenosis
  • prior surgery for carotid artery stenosis
  • total occlusion of the internal carotid artery

Outcomes

Primary Outcomes

Recurrent ischemic CVA or TIA

Time Frame: up to four years

Recurrent ischemic CVA or TIA from first ischemic CVA or TIA after 31-12-2010 until date of first documented recurrence, assessed up to four years

Secondary Outcomes

  • 'New' diagnosis of AF(Up to four years)

Study Sites (1)

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