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Status: Recruiting
Location: See all (26) locations...
Intervention Type: Genetic
Study Type: Observational
SUMMARY

The increased risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) related to vigorous physical activity is well-documented. Currently, for young victims (under 35 years) of SCA/SCD, no etiology is found in 40 to 50% of cases after a standard medical assessment, leading to two important consequences. For the victim's family, it is difficult to understand and accept this tragic event, and the risk of it occurring in another family member is a source of concern. Medically, the absence of a known cause limits the ability to effectively prevent such events. The RESOUDRE study will be a national, prospective, observational registry of young victims (12-35 years) of sports-related SCA/SCD. All cases will undergo the recommended etiological assessment, including autopsy for SCA cases, along with whole exome genetic analysis and toxicological testing. In the event a genetic pathology is identified, a genetic evaluation will be offered to other family members, and appropriate medical care will be provided if necessary. The results of this study could significantly reduce the number of unexplained sport-related SCA/SCD cases and aid in preventing these incidents among affected families.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 35
Healthy Volunteers: f
View:

• Victims of SCA:

‣ Aged between 12 and 35 years

⁃ No known cardiovascular pathology

⁃ Experienced a sudden and non-traumatic SCA during or within one hour of participating in sports activities (leisure, training, or competition)

⁃ For resuscitated victims (SCA group): A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, organs, or authorities responsible for assisting or representing them if they are unable to express their wishes).

⁃ For non-resuscitated victims (SCD group): A person who has not formally objected to the reuse of their medical data during their lifetime.

• First-Degree Relatives:

‣ A person or legal representative who does not oppose participation in the research after being informed about the study (including individuals, bodies, or authorities responsible for assisting or representing them if they are unable to express their wishes).

Locations
Other Locations
France
CHRU Besançon
NOT_YET_RECRUITING
Besançon
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Brest
NOT_YET_RECRUITING
Brest
CHU Caen
NOT_YET_RECRUITING
Caen
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
APHP Hôpital Henri-Mondor
NOT_YET_RECRUITING
Créteil
CHU Dijon Bourgogne
NOT_YET_RECRUITING
Dijon
CHU de Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
CHRU Lille
NOT_YET_RECRUITING
Lille
Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
APHM Hôpitaux universitaires de Marseille
NOT_YET_RECRUITING
Marseille
CHRU Montpellier
NOT_YET_RECRUITING
Montpellier
CHRU Nancy
NOT_YET_RECRUITING
Nancy
CHU Nantes
NOT_YET_RECRUITING
Nantes
CHU de Nice
RECRUITING
Nice
APHP Hôpital Bichat
NOT_YET_RECRUITING
Paris
APHP Hôpital Européen Georges Pompidou
NOT_YET_RECRUITING
Paris
APHP Hôpital Pitié-Salpêtrière
NOT_YET_RECRUITING
Paris
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Reims
NOT_YET_RECRUITING
Reims
CHU Rennes
RECRUITING
Rennes
CHU Rouen
NOT_YET_RECRUITING
Rouen
CHU Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
CHRU Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
CHRU Tours
RECRUITING
Tours
Contact Information
Primary
Frédéric SCHNELL
frederic.schnell@chu-rennes.fr
0299284133
Backup
Stéphanie Jolly
stephanie.jolly@chu-rennes.fr
0299282555
Time Frame
Start Date: 2024-10-11
Estimated Completion Date: 2028-01-11
Participants
Target number of participants: 80
Treatments
Victims of sport-related sudden cardiac arrest (SCA) : resuscitated SCA and non-resuscitated SCA
Following a sport-related sudden cardiac arrest (SCA), resuscitation attempts are frequently made due to the high likelihood of witnesses at the scene. These resuscitation efforts are successful in more than 40% of cases. The study population will therefore be divided into two groups: a group of resuscitated SCA victims (SCA group) and a group of non-resuscitated or unsuccessfully resuscitated victims (SCD group).~The RESOUDRE study is an observational study focusing on individuals who have experienced SCA. Depending on the outcome-whether the individual survives or not-the etiological assessment will differ. While the study design refers to two distinct groups for clarity, they represent a single population, and no statistical comparison between the two groups will be made.
Related Therapeutic Areas
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov