Sudden DeathAGEMOSNCT02920203
Genetic Autopsy and Sudden Death
An observational study of Sudden Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Sudden Death
- What is being tested?
- Heart and spleen tissue
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2017to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Index cases enrolled: series of consecutive and exhaustive cases recruited by forensic institutes or pathology departements Relatives enrolled: as many as possible during the recruitment period
Who may be able to join
- Subjects of more than 2 years old and less than 41 years old
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Raymond Poincaré hospital
Garches, 92380
Geoffroy Lorin de la Grandmaison, Pr, +33(0)1 47 10 76 90, g.lorin@aphp.fr
About this study
Official title: Genetic Autopsy and Sudden Death of Young Subject
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
Read the 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
- Conditions
- Sudden Death
- Being tested
- Heart and spleen tissue
- Keywords
- Sudden unexpected death, young subjects, molecular genetic autopsy, sequencing
- Medical subject headings
- Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart and spleen tissueGenetic
genetic sequencing
| Study group | Role | What they receive |
|---|---|---|
| index cases group | unexpected sudden death cases recruited by forensic institutes or pathology departements Receives: Genetic: Heart and spleen tissue | |
| first degree relatives group | Relatives enrolled of unexpected sudden death index cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sudden death elucidation rate obtained by high throughput sequencing (NGS) versus conventional autopsy (macroscopic and / or microscopic)
Aim is to determine if elucidation rate of unexpected sudden death causes obtained by high throughput sequencing (NGS) is significantly better than conventional autopsy (macroscopic and / or microscopic) alone.
Inclusion of a series of 100 consecutive and exhaustive cases (index cases) recruited by forensic institutes or pathology departements.
Determine the rate of sudden death elucidation after NGS (after targeted capturing of 100 genes responsible for inherited cardiac diseases, including cardiomyopathy and electrical diseases) and comparison of sudden death elucidation rate obtained with conventional autopsy (macroscopic and microscopic) by chi 2 analysis.
Measured: 27 months
Secondary outcomes (3)
Describe the epidemiology of causes of sudden death
Inclusion of a serie of consecutive and exhaustive subjects recruited by forensic institutes or pathology departements.
Determination all the causes of death after conventional autopsy (unnatural, toxicological, non-cardiovascular, vascular, cardiological and coronary, cardiological and non-coronary causes such as cardiomyopathies \& myocarditis, no cause identified Descriptive analysis. All quantitative data will be analyzed with the average, standard deviation and median.
Frequencies and Clopper-Pearson confidence interval of 95% will be provided
Measured: 27 months
Comparison of elucidation rates of cause of sudden death including systematic cardiac screening in relatives
Aim is to determine the impact of systematic family cardiac screening in the understanding of sudden deaths Comparison of elucidation rates of cause of sudden death according to three methods:
- identification of a hereditary heart disease via the systematic cardiac screening performed in relative; ii) by the conventional autopsy; iii) by sequencing NGS analysis; Statistics: test of McNemar (mated series). The threshold for level of statistical significance is chosen at 5 %.
Measured: 39 months
Medico-economic modeling of the various diagnostic approaches
Cost-effectiveness modeling evaluation of medical and economic impact of the genetic molecular autopsy, efficacy being estimated by years of life saved in the family
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start11 Oct 2017
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden DeathStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Pathology department and forensic Institute, Raymond Poincaré hospital, Garches, Pitié-Salpêtrière Hospital, Clinical research Unit, Ambroise Paré Hospital, Boulogne Billancourt, Molecular and medical Virology Laboratory, Medical School, Reims
- Responsible party
- Sponsor
- Investigators
- Geoffroy Lorin de la Grandmaison, Pr, Principal investigator, Assistance Publique Hoptiaux de ParisPhilippe Charron, MD, PhD, Study director, +33 (0)1 42 16 13 47
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920203
- Sponsor's protocol ID
- NI 13007
- Acronym
- AGEMOS
- Status last verified
- Nov 2017
- First submitted
- 7 Sep 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Autopsy and Sudden Death of Young Subject
- ClinicalTrials.gov ID
- NCT02920203
- Acronym / sponsor ID
- AGEMOS / NI 13007
- Conditions
- Sudden Death
- Keywords
- Sudden unexpected death, young subjects, molecular genetic autopsy, sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Pathology department and forensic Institute, Raymond Poincaré hospital, Garches, Pitié-Salpêtrière Hospital, Clinical research Unit, Ambroise Paré Hospital, Boulogne Billancourt, Molecular and medical Virology Laboratory, Medical School, Reims
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| index cases group | – | Genetic: Heart and spleen tissueunexpected sudden death cases recruited by forensic institutes or pathology departements |
| first degree relatives group | – | –Relatives enrolled of unexpected sudden death index cases |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Index cases enrolled: series of consecutive and exhaustive cases recruited by forensic institutes or pathology departements Relatives enrolled: as many as possible during the recruitment period
Key inclusion criteria (8 listed)
- Subjects of more than 2 years old and less than 41 years old
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart and spleen tissuegenetic sequencing | Genetic | index cases group |
Primary outcome
Comparison of sudden death elucidation rate obtained by high throughput sequencing (NGS) versus conventional autopsy (macroscopic and / or microscopic)
Time frame: 27 months
Aim is to determine if elucidation rate of unexpected sudden death causes obtained by high throughput sequencing (NGS) is significantly better than conventional autopsy (macroscopic and / or microscopic) alone. Inclusion of a series of 100 consecutive and exhaustive cases (index cases) recruited by forensic institutes or pathology departements. Determine the rate of sudden death elucidation after NGS (after targeted capturing of 100 genes responsible for inherited cardiac diseases, including cardiomyopathy and electrical diseases) and comparison of sudden death elucidation rate obtained with conventional autopsy (macroscopic and microscopic) by chi 2 analysis.
3 secondary outcomes
Describe the epidemiology of causes of sudden death
Time frame: 27 months
Comparison of elucidation rates of cause of sudden death including systematic cardiac screening in relatives
Time frame: 39 months
Medico-economic modeling of the various diagnostic approaches
Time frame: 39 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffroy Lorin de la Grandmaison, Pr principal investigator
Assistance Publique Hoptiaux de Paris
Philippe Charron, MD, PhD study director
+33 (0)1 42 16 13 47
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Death, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geoffroy Lorin de la Grandmaison, Pr (+33(0)1 47 10 76 90, g.lorin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sudden death elucidation rate obtained by high throughput sequencing (NGS) versus conventional autopsy (macroscopic and / or microscopic) (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.