Left Atrial Function in Recurrent Stroke of Unknown Cause

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Jessa Ziekenhuis

Hasselt, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
carotid artery dissection
vertebral artery dissection
massive aortic atheromatosis
temporal arteritis
basilar artery aneurysm
ascending aortic aneurysm
subclavian steal
prior CVA/TIA
intracerebral hemorrhage
lacunar infarction
clotting disorder
on anticoagulants
CVA/TIA as a procedural complication
hyperthyroidism
patients who died in hospital after first admission for CVA/TIA

Treatment and study plan

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

Time frame: Up to four years

'New' diagnosis of AF from first ischemic CVA or TIA after 31-12-2010 until date of documented 'new' AF, assessed up to four years

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

Jessa Hospital

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 18, 2016
Registry last updated: Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed