Register and DNA Bank of Adult Extra-hospital Sudden Death
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Identification of variants in DNA
研究概览
简要总结
The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.
The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.
研究设计
- 研究类型
- Interventional
- 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
- •Inclusion criteria for register :
- •Adults ≥ 18 years of age.
- •Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
- •Patients not hospitalized at the time of sudden death.
- •Inclusion criteria for DNA bank :
- •Case subjects :
- •Adults ≥ 18 years of age.
- •Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
- •Patients not hospitalized at the time of sudden death.
- •Patients supported clinically by an emergency ambulance service.
- •Control subjects :
- •Adults ≥ 18 years of age.
- •Adults hospitalized in an cardiac intensive care unit.
排除标准
- •Exclusion criteria for register :
- •Violent death : criminal, suicidal or accidental.
- •Exclusion criteria for DNA bank :
- •Case subjects :
- •Violent death : criminal, suicidal or accidental.
- •Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.
- •In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :
- •Adult subject to legal protection measure,
- •Pregnant woman,
- •Parturient,
- •Breastfeeding mother,
- •Person deprived of liberty,
- •Person hospitalised without his consent,
- •Person admitted to a medical or socially facility.
- •Control subjects :
- •History of sudden death,
- •Documented history of ventricular fibrillation,
- •History of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.
研究组 & 干预措施
Case subjects
干预措施: Case Controls (Other)
Control subjects
干预措施: Control subjects (Other)
结局指标
主要结局
Identification of variants in DNA
The primary endpoint is the identification of variants (polymorphisms and / or mutations) in DNA significantly associated with risk of extra-hospital sudden death in adults. Study populations are : (i) the entire population of case subjects included in the DNA bank (ii) two subpopulations at high risk of sudden death : patients with a history of myocardial infarction and patients with LVEF \< 30 %. The variable analyzed is the nucleotide sequence of DNA in populations of case and control subjects.
次要结局
- Annual incidence of extra-hospital sudden death in adults
- Annual mortality related to extra-hospital sudden death in adults
- Characterization of victims of extra-hospital sudden death in adults