Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01321918
Eligibility Criteria:
INCLUSION CRITERIA :
* 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.
EXCLUSION CRITERIA :
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01321918
Study Brief:
Protocol Section:
NCT01321918