Left Atrial Function in Recurrent Stroke of Unknown Cause

Completed

• Conditions: Stroke

• Registration Number: NCT02968329
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• CVA
• TIA

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrent ischemic CVA or TIA	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 Outcome Measures

Name	Time	Method
'New' diagnosis of AF	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

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium