跳至主要内容
临床试验/NCT03611816
NCT03611816招募中不适用

Biological Bank for Studies Related to Atrial Fibrillation and Stroke

Hospices Civils de Lyon10 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
10
主要终点
Quality of Plasma sample

研究概览

简要总结

Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria :
  • - AF history

排除标准

  • No AF history
  • patient who didn't signed consent
  • Inclusion Criteria :
  • AF history
  • Scheduled electrophysiological exploration or AF ablation
  • Exclusion Criteria :
  • No AF history
  • pregnant women
  • patient who didn't signed consent
  • Inclusion Criteria :
  • AF/AT history
  • Stroke history
  • Exclusion Criteria :
  • No Stroke history
  • patient who didn't signed consent
  • Inclusion Criteria :
  • patient over 80
  • ECG: sinusal rhythm
  • TTE : no left atrial dilatation
  • Exclusion Criteria :
  • atrial fibrillation history
  • TTE : Left atria >25cm², > 34m/m2), FEVG < 50%
  • ECG : QRS > 90 ms
  • cardiac pathologies (excepted hypertension and valvulopathies)
  • History of stroke and transient ischemic attack
  • patient who didn't signed consent
  • Inclusion Criteria :
  • cryptogenic stroke or transient ischemic attack history before 50 yo
  • No AF history
  • Exclusion Criteria :
  • AF history
  • stroke or transient ischemic attack over 50 yo
  • patient who didn't signed consent

研究组 & 干预措施

Group 1a

Patient with atrial fibrillation and without stroke history.

干预措施: Blood taken (Genetic)

Group 2

Patients aged over 80 years old and without history of atrial fibrillation.

干预措施: Blood taken (Genetic)

Group 3

Patient with cryptogenic stroke or transient ischemic attack history before the age of 50.

干预措施: Blood taken (Genetic)

Group 1b

Patient with atrial fibrillation with scheduled electrophysiology exploration or ablation.

干预措施: Blood taken (Genetic)

Group 1c

Patient with atrial fibrillation and with stroke history.

干预措施: Blood taken (Genetic)

结局指标

主要结局

Quality of Plasma sample

时间窗: 1 day (the day of the storage)

Quality is based on the purity of Plasma sample that is based on absence of hemolyzed blood by visual observation.

Quality of DNA sample

时间窗: 1 day (the day of the storage)

Quality is based on the measure of the purity of DNA with absorbance assay at 260/280nm on a spectrophotometer. For Plasma sample, purity is based on absence of hemolyzed blood by visual observation.

Quality of preservation of the sample

时间窗: 7 years (during all the duration of the collection)

The quality of preservation of the sample throughout the conservation duration is based on the number of freezing/thawing of each cryotube that will be notified. As weel as any interruption in the freezing process (power failure, freezer failure).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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