Left Atrial Function in Recurrent Stroke of Unknown Cause
NCT ID: NCT02968329
Last Updated: 2017-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2016-10-31
2017-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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CVA cases
patients who experienced an ischemic CVA or TIA during the study duration and experienced a recurrence.
No interventions assigned to this group
CVA controls
patients who experienced an ischemic CVA or TIA during the study duration, but who didn't experience a recurrence.
No interventions assigned to this group
AF cases
patients who experienced an ischemic CVA or TIA during the study duration and who got diagnosed with 'new' AF
No interventions assigned to this group
AF controls
patients who experienced an ischemic CVA or TIA during the study duration but who didn't get diagnosed with 'new' AF during the study duration
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* TIA
Exclusion Criteria
* 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
ALL
No
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Responsible Party
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prof. dr. Paul Dendale
prof. dr.
Principal Investigators
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Paul Dendale, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Jessa Hospital
Bram Verdonck, student
Role: STUDY_CHAIR
Hasselt University
Jens Jeurissen, student
Role: STUDY_CHAIR
Hasselt University
Locations
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Jessa Ziekenhuis
Hasselt, , Belgium
Countries
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Other Identifiers
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JJBV544
Identifier Type: -
Identifier Source: org_study_id
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