Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
RESOUDRE
Registre Prospectif Français Des Morts Subites Chez Des Sportifs Jeunes
1 other identifier
observational
80
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2024
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2024
CompletedStudy Start
First participant enrolled
October 11, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 11, 2028
January 8, 2025
January 1, 2025
3.3 years
October 8, 2024
January 7, 2025
Conditions
Keywords
Outcome Measures
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.
Through study completion, approximately 39 months
Secondary Outcomes (5)
Evaluation of the Contribution of Medical Autopsy in Identifying the Etiology of Sports-Related SCA
3 to 6 months after the event
Evaluation of the Contribution of Classical Genetic Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
3 to 6 months after the event
Evaluation of the Contribution of Whole Exome Sequencing in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
24 to 30 months after the event
Evaluation of the Contribution of Toxicological Analysis in Identifying the Etiology of Sports-Related Cardiorespiratory Arrest
3 to 6 months after the event
Evaluation of the Familial Transmission of Hereditary Cardiovascular Pathologies Detected
3 to 12 months after the event.
Study Arms (1)
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.
Interventions
Whole exome sequencing to detect myocardial genetic mutations
Eligibility Criteria
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.
You may qualify if:
- 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).
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
APHP Hôpital Bichat
Paris, France, 75877, France
APHP Hôpital Européen Georges Pompidou
Paris, France, 75908, France
CHU Rennes
Rennes, France, 35000, France
CHRU Besançon
Besançon, 25030, France
CHU Bordeaux
Bordeaux, 33600, France
CHU Brest
Brest, 29609, France
CHU Caen
Caen, 14033, France
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
APHP Hôpital Henri-Mondor
Créteil, 94010, France
CHU Dijon Bourgogne
Dijon, 21079, France
CHU de Grenoble Alpes
Grenoble, 38700, France
CHRU Lille
Lille, 59037, France
Hospices Civils de Lyon
Lyon, 69229, France
APHM Hôpitaux universitaires de Marseille
Marseille, 13364, France
CHRU Montpellier
Montpellier, 34295, France
CHRU Nancy
Nancy, 54035, France
CHU Nantes
Nantes, 44093, France
CHU de Nice
Nice, 06003, France
APHP Hôpital Pitié-Salpêtrière
Paris, 75651, France
CHU Poitiers
Poitiers, 86000, France
CHU Reims
Reims, 51092, France
CHU Rouen
Rouen, 76031, France
CHU Saint-Etienne
Saint-Etienne, 42100, France
CHRU Strasbourg
Strasbourg, 67091, France
CHU Toulouse
Toulouse, 31059, France
CHRU Tours
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric SCHNELL
Study Principal Investigator
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2024
First Posted
October 15, 2024
Study Start
October 11, 2024
Primary Completion (Estimated)
January 11, 2028
Study Completion (Estimated)
January 11, 2028
Last Updated
January 8, 2025
Record last verified: 2025-01