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Recruiting NCT06642168

NCT06642168 Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register

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Clinical Trial Summary
NCT ID NCT06642168
Status Recruiting
Phase
Sponsor Rennes University Hospital
Condition Sudden Cardiac Arrest
Study Type OBSERVATIONAL
Enrollment 80 participants
Start Date 2024-10-11
Primary Completion 2028-01-11

Trial Parameters

Condition Sudden Cardiac Arrest
Sponsor Rennes University Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 12 Years
Max Age 35 Years
Start Date 2024-10-11
Completion 2028-01-11
Interventions
Whole exome sequencing to detect myocardial genetic mutations (SCA group only)

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Brief 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 Criteria

Inclusion Criteria: * 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). Non-Inclusion Criteria:

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