Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-31 @ 6:22 AM
Study NCT ID:
NCT02920203
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Autopsy and Sudden Death
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Genetic Autopsy and Sudden Death of Young Subject
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AGEMOS
Brief Summary:
The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue
Detailed Description:
Monitoring :
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: