跳至主要内容
临床试验/NCT02968329
NCT02968329已完成不适用

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

Hasselt University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Recurrent ischemic CVA or TIA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Recurrent ischemic CVA or TIA

时间窗: 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

次要结局

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

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Paul Dendale

prof. dr.

Hasselt University

研究点 (1)

Loading locations...

相似试验