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临床试验/NCT03824509
NCT03824509已完成不适用

Echocardiographic Risk Factors of Stroke in Patients With Atrial

MaineHealth1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
MaineHealth
入组人数
140
试验地点
1
主要终点
Stroke outcome

研究概览

简要总结

The goal is to review patients with known atrial fibrillation who suffered a stroke or transient ischemic attack (TIA) to incorporate any structural heart abnormalities into the overall clinical picture. A better understanding of the additional risk of a stroke or TIA in patients with specific structural abnormalities may be beneficial in guiding future treatment decisions.

详细描述

Atrial fibrillation is the most common heart rhythm disorder seen in clinical practice. Patients with atrial fibrillation are at increased risk for stroke. This risk is determined by several factors. Congestive heart failure, hypertension, age, diabetes, female sex, previous history of heart attack or vascular disease, and previous history of stroke all increase a patients' risk for clot formation and stroke. These risk factors have been formulated into a scoring system called the CHA2DS2-VASc score. A score of greater than 2 on this scale indicates a moderate to high risk for clot formation and stroke. Anticoagulation medications are recommended in these patients. Non-traditional risk factors such as left atrial size and left ventricular hypertrophy have also been associated with increased stroke risk. These factors have not yet been routinely incorporated into treatment decisions regarding anticoagulation and stroke prevention.

This study is an expansion of an initial pilot conducted at Pen Bay Medical Center of patient records from 2014-2017. This pilot found 19 patients with a recorded stroke or TIA, history of atrial fibrillation, and CHA2DS2-VASc score of 2 or lower within that time period. This study will be an expansion of that pilot to include patient data from Maine Medical Center.

This study aims to look at these non-traditional risk factors in patients who have an otherwise low stroke risk based on the CHA2DS2-VASc score.

Our specific aims are:

  1. Assess left atrial volume using volumetric measurements and left ventricular septal and posterior wall thickness from 2-D transthoracic echocardiography studies in patients with known atrial fibrillation who suffered a stroke or TIA. The investigator would then compare these data to control patients with atrial fibrillation with matched CHA2DS2-VASc scores, age (+/- 5 years), and gender who have no history of stroke or TIA. The goal is to identify higher risk patients with alternate anatomy who otherwise would be considered lower risk using traditional risk scoring methods. Identifying these individuals may lead to more aggressive interventions and subsequently may help in reducing the risk of stroke.
  2. Assess stroke outcome as measured by NIH Stroke Scale and/or Modified Rankin Scale score, in the population of patients with atrial fibrillation who suffered a stroke to identify any potential differences associated with structural changes. If structural changes are associated with stroke severity, echocardiogram findings again may aid in guiding treatment decisions for patients with atrial fibrillation.

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

  • Patients with a CHA2DS2-VASc score greater than 2

结局指标

主要结局

Stroke outcome

时间窗: 12 months

Compare structural changes found on echocardiogram to stroke severity, as measured by NIH Stroke Scale and/or Rankin Score.

Left atrial volume

时间窗: 12 months

1)Assess left atrial volume using volumetric measurements and left ventricular septal and posterior wall thickness from 2-D transthoracic echocardiography studies in patients with known atrial fibrillation who suffered a stroke or TIA. We would then compare these data to control patients with atrial fibrillation with matched CHA2DS2-VASc scores, age (+/- 5 years), and gender who have no history of stroke or TIA.

次要结局

未报告次要终点

研究者

发起方
MaineHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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