AssesSment of the Left Atrial Appendage morphoLogy in Patients aAfter ischeMic Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
研究概览
简要总结
Stroke remains the most dangerous and frightening complication of atrial fibrillation (AF). Numerous factors predisposing to peripheral embolism in patients with AF have been well defined, documented and included in the CHA2DS2VASC score. Although proper anticoagulation minimizes the risk attributable to "known" risk factors, stroke may still occur. Thus, "unknown" risk factors may play an important role in stroke risk stratification in patients with AF. The investigators assume that one of the important "unknown" risk factor is left atrial appendage (LAA) morphology. The ASSAM study is planned to include 100 patients after ischemic stroke or transient ischemic attack (TIA) and known status of anticoagulation at the time of stroke. The control group will consist of 100 patients scheduled for AF ablation without a history of stroke or TIA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •history of ischemic stroke or transient ischemic attack
- •history of AF/AL
- •known status of anticoagulation at the time of stroke (treatment dose, INR level)
排除标准
- •hemorrhagic stroke
- •serious renal impairment with GFR <30 ml/min
- •hyperthyroidism
- •allergy to the contrast agent
- •mental inability to sign the informed consent
- •receptive aphasia
结局指标
主要结局
The LAA morphology in patients with an elevated risk of peripheral thromboembolism defined as CHA2DS2-VAScore >2
时间窗: Through study completion, an average of 1 year
The investigators will examine association of specific type of LAA morphology with ischemic stroke taking in to account anticoagulation in the time of stroke/TIA. The morphology of LAA will be divided into 4 types: * the chicken wing - LAA with only one lobe, its length exceeds 40 mm and its bend angle is less than 100 degrees * the windsock - LAA with one dominant lobe (length \> 40 mm) and several secondary, or even tertiary ones, its length exceeds 40 mm and its bend angle exceeds 100 degrees * the cauliflower - LAA with a variable number of lobes with lack of a dominant lobe, its total length is less than 40 mm * the cactus - LAA with a dominant central lobe with several secondary ones, its total length less than 40 mm
次要结局
未报告次要终点
研究者
Jakub Baran MD PhD
Principal Investigator
Centre of Postgraduate Medical Education