NCT06642168 Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-10-11 with a primary completion date of 2028-01-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: * For resuscitated SCA cases, individuals weighing less than 20 kg * Victims or legal representatives who are subject to legal protection or deprived of their liberty
Contact & Investigator
Frédéric SCHNELL
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06642168 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 35 Years, studying Sudden Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06642168 currently recruiting?
Yes, NCT06642168 is actively recruiting participants. Contact the research team at frederic.schnell@chu-rennes.fr for enrollment information.
Where is the NCT06642168 trial being conducted?
This trial is being conducted at Nîmes, France, Paris, France, Paris, France, Rennes, France and 11 additional locations.
Who is sponsoring the NCT06642168 clinical trial?
NCT06642168 is sponsored by Rennes University Hospital. The principal investigator is Frédéric SCHNELL at Study Principal Investigator. The trial plans to enroll 80 participants.