跳至主要内容
临床试验/NCT02847039
NCT02847039Unknown不适用

Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Incidence of ventricular fibrillation or sudden death

研究概览

简要总结

The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.

To try to answer these many questions, the approach will be twofold: clinical and genetic.

  • Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
  • Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
  • 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.

A blood sample (15 ml) will be performed at inclusion.

研究设计

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

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
  • Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
  • Late potentials ventricular analyzable.
  • For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
  • For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.

排除标准

  • Impossibility to receive clear information (patient's intellectual default).
  • Refusal to sign the informed consent for participation.
  • Under protective measure of justice.

结局指标

主要结局

Incidence of ventricular fibrillation or sudden death

时间窗: 36 months

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 (1)

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