Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2017-10-11
2020-12-31
Brief Summary
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Detailed Description
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For index cases group, all the data will be monitored. For the relatives group, only the informed consent will be monitored
Statistical analysis :
* Evaluate the additional elucidation rate of unexpected sudden death
* Evaluate causes obtained by Next Generation Sequencing (NGS) ( in comparison with conventional autopsy (macroscopic and / or microscopic)
* Descriptive study of the causes of sudden unexpected death, identified hereditary cardiac causes percentages compared via various diagnostic approaches
* Cost-effectiveness analysis
Data Management :
A database is created for the AGEMOS study with control of the discrepancies. All the index cases' data entered in the data base will be double checked
Conditions
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Keywords
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Study Design
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FAMILY_BASED
PROSPECTIVE
Study Groups
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index cases group
unexpected sudden death cases recruited by forensic institutes or pathology departements
Heart and spleen tissue
genetic sequencing
first degree relatives group
Relatives enrolled of unexpected sudden death index cases
No interventions assigned to this group
Interventions
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Heart and spleen tissue
genetic sequencing
Eligibility Criteria
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Inclusion Criteria
* Sudden unexpected death from natural and nontraumatic causes
* Macroscopic autopsy performed within 72 hours after death and without signs of body decomposition
* No extracardiac obvious causes, including toxicological analysis when available
* No significant coronary cause after autopsy (such as tight coronary stenosis, congenital abnormality of the arteries, coronary vasculitis)
* Informed consent of the close relation (family/reliable person) and / or legal representative
Relatives :
* To be a first degree relative (parents, sister, brother, child) of a deceased subject included in the AGEMOS study and accept to perform medical examination and transmit results of examination
2 Years
40 Years
ALL
No
Sponsors
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Pathology department and forensic Institute, Raymond Poincaré hospital, Garches
UNKNOWN
Referal Center for Inherited cardiac diseases, Pitié Salpêtrière Hospital, Paris
UNKNOWN
Pitié-Salpêtrière Hospital
OTHER
Clinical research Unit, Ambroise Paré Hospital, Boulogne Billancourt
UNKNOWN
Cardiogenetic and molecular and cellular myogenetic functionnal unit Pitié Salpêtrière hospital, Paris
UNKNOWN
Molecular and medical Virology Laboratory, Medical School, Reims
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Geoffroy Lorin de la Grandmaison, Pr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique Hoptiaux de Paris
Philippe Charron, MD, PhD
Role: STUDY_DIRECTOR
+33 (0)1 42 16 13 47
Locations
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Raymond Poincaré hospital
Garches, , France
Countries
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Central Contacts
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Geoffroy Lorin de la Grandmaison, Pr
Role: CONTACT
Phone: +33(0)1 47 10 76 90
Email: [email protected]
Facility Contacts
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Geoffroy Lorin de la Grandmaison, Pr
Role: primary
Other Identifiers
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NI 13007
Identifier Type: -
Identifier Source: org_study_id