NCT02847039Unknown不适用
Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study
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
- 否
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
研究点 (1)
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