Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-35
SponsorRennes University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
None
Trial population
The study will include French victims of sports-related SCA/SCD between the ages of 12 and 35, as well as their first-degree relatives over 12 years of age, when applicable.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Whole exome sequencing to detect myocardial genetic mutations (SCA group only)
GeneticWhole exome sequencing to detect myocardial genetic mutations
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Victims of sport-related sudden cardiac arrest (SCA) : resuscitated SCA and non-resuscitated SCA1 intervention
Trial outcomes
Primary outcomes
1
Identification of the Cause of Sports-Related Cardiorespiratory Arrest in a Young, Healthy Population
The results for each identified cause of sports-related cardiorespiratory arrest will be presented as the total number of cases (n) and the percentage of the total cases. A 95% confidence interval will also be provided.
Time frame
Through study completion, approximately 39 monthsSecondary outcomes
1
Evaluation of the Contribution of Medical Autopsy in Identifying the Etiology of Sports-Related SCA
Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.
Time frame
3 to 6 months after the event2
Evaluation of the Contribution of Classical Genetic Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
The results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.
Time frame
3 to 6 months after the event3
Evaluation of the Contribution of Whole Exome Sequencing in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.
Time frame
24 to 30 months after the event4
Evaluation of the Contribution of Toxicological Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.
Time frame
3 to 6 months after the eventSponsors and contacts
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Source ClinicalTrials.gov