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Sudden Cardiac ArrestRESOUDRENCT06642168

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

An observational study of Sudden Cardiac Arrest and Sudden Cardiac Death, run by Rennes University Hospital at 26 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 35 years
Conditions the study is for
Sudden Cardiac Arrest, Sudden Cardiac Death
What is being tested?
Whole exome sequencing to detect myocardial genetic mutations (SCA group only)
How many people
80 participants
Where
26 sitesFrance
Study dates
11 Oct 2024to 11 Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study 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.

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

26 sites in 1 country

France26 sites, 26 recruiting
  • CHU Bordeaux

    Bordeaux, 33600

    Frédéric SACHER, frederic.sacher@chu-bordeaux.fr

    Frédéric SACHER

    Recruiting
  • CHU Brest

    Brest, 29609

    Jacques MANSOURATI, jacques.mansourati@chu-brest.fr

    Jacques MANSOURATI

    Not yet recruiting
  • CHU Caen

    Caen, 14033

    Amir HODZIC, hodzic-a@chu-caen.fr

    Amir HODZIC

    Recruiting
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Romain ESCHALIER, reschalier@chu-clermontferrand.fr

    Romain ESCHALIER

    Recruiting
  • APHP Hôpital Henri-Mondor

    Créteil, 94010

    Nicolas LELLOUCHE, nicolas.lellouche@aphp.fr

    Nicolas LELLOUCHE

    Not yet recruiting
  • CHU Dijon Bourgogne

    Dijon, 21079

    Gabriel LAURENT, gabriel.laurent@chu-dijon.fr

    Gabriel LAURENT

    Not yet recruiting
  • CHU de Grenoble Alpes

    Grenoble, 38700

    Pascal DEFAYE, PDefaye@chu-grenoble.fr

    Pascal DEFAYE

    Not yet recruiting
  • CHRU Lille

    Lille, 59037

    Didier KLUG, Didier.KLUG@chu-lille.fr

    Didier KLUG

    Recruiting
  • Hospices Civils de Lyon

    Lyon, 69229

    Philippe CHEVALIER, philippe.chevalier@chu-lyon.fr

    Philippe CHEVALIER

    Not yet recruiting
  • APHM Hôpitaux universitaires de Marseille

    Marseille, 13364

    Jean-Claude DEHARO, JeanClaude.DEHARO@ap-hm.fr

    Jean-Claude DEHARO

    Recruiting
  • CHRU Montpellier

    Montpellier, 34295

    Jean-Luc PASQUIE, jl-pasquie@chu-montpellier.fr

    Jean-Luc PASQUIE

    Recruiting
  • CHRU Nancy

    Nancy, 54035

    Etienne ALIOT, E.ALIOT@chru-nancy.fr

    Etienne ALIOT

    Not yet recruiting
  • CHU Nantes

    Nantes, 44093

    Vincent PROBST, vincent.probst@chu-nantes.fr

    Vincent PROBST

    Recruiting
  • CHU de Nice

    Nice, 06003

    Didier SCARLATTI, scarlatti.d@chu-nice.fr

    Didier SCARLATTI

    Recruiting
  • CHU Nîmes

    Nîmes, France, 30029

    Camille SOULLIER, camille.SOULLIER@chu-nimes.fr

    Camille SOULLIER

    Not yet recruiting
  • APHP Hôpital Bichat

    Paris, France, 75877

    Fabrice EXTRAMIANA, fabrice.extramiana@aphp.fr

    Fabrice EXTRAMIANA

    Not yet recruiting
  • APHP Hôpital Européen Georges Pompidou

    Paris, France, 75908

    Eloi MARIJON, eloi.marijon@aphp.fr

    Eloi MARIJON

    Recruiting
  • APHP Hôpital Pitié-Salpêtrière

    Paris, 75651

    Estelle GANDJBAKHCH, estelle.gandjbakhch@aphp.fr

    Estelle GANDJBAKHCH

    Recruiting
  • CHU Poitiers

    Poitiers, 86000

    Rodrigue GARCIA, rodrigue.garcia@chu-poitiers.fr

    Rodrigue GARCIA

    Recruiting
  • CHU Reims

    Reims, 51092

    François LESAFFRE, flesaffre@chu-reims.fr

    François LESAFFRE

    Not yet recruiting
  • CHU Rennes

    Rennes, France, 35000

    Frédéric SCHNELL, frederic.schnell@chu-rennes.fr

    Frédéric SCHNELL

    Recruiting
  • CHU Rouen

    Rouen, 76031

    Frédéric ANSELME, Frederic.Anselme@chu-rouen.fr

    Frédéric ANSELME

    Not yet recruiting
  • CHU Saint-Etienne

    Saint-Etienne, 42100

    Antoine DA COSTA, antoine.dacosta@univ-st-etienne.fr

    Antoine DA COSTA

    Recruiting
  • CHRU Strasbourg

    Strasbourg, 67091

    Laurence JESEL-MOREL, Laurence.JESEL-MOREL@chru-strasbourg.fr

    Laurence JESEL-MOREL

    Not yet recruiting
  • CHU Toulouse

    Toulouse, 31059

    Philippe MAURY, maury.p@chu-toulouse.fr

    Philippe MAURY

    Recruiting
  • CHRU Tours

    Tours, 37044

    Fabrice IVANES, F.IVANES@chu-tours.fr

    Fabrice IVANES

    Recruiting

Other trials in France

About this study

Official title: Registre Prospectif français Des Morts Subites Chez Des Sportifs Jeunes

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.

Read the detailed description

Background:

The beneficial effects of moderate physical activity on health are well-established. However, it is also well-proven that intense sports participation increases the risk of cardiovascular events by 2.4 to 4.5 times before the age of 35 in individuals with known or unknown heart conditions. Sudden cardiac arrest (SCA), sometimes leading to sudden cardiac death (SCD), is the most dramatic event linked to sports.

Before the age of 35, sports-related SCA/SCD is rare, occurring in 0.7 to 2.7 per 100,000 athletes, which amounts to approximately 80 cases per year according to two French prospective studies. Despite its rarity, these events are often traumatic and highly publicized, presenting a significant public health and safety concern. Non-traumatic sports-related SCA/SCD is primarily of cardiovascular origin, irrespective of the level of sports participation. In most cases, SCA results from ventricular arrhythmia caused by known or undiagnosed arrhythmogenic cardiovascular disease, which varies by the victim's age. After the age of 35, atheromatous coronary artery disease accounts for 80-85% of cases. However, before the age of 35, a wider range of etiologies are observed. Arrhythmogenic genetic heart diseases-structural (e.g., arrhythmogenic right ventricular cardiomyopathy and hypertrophic cardiomyopathy) or non-structural (e.g., channelopathies)-are the most frequent causes. Congenital abnormalities, particularly anomalous connection of coronary artery, represent the second most common cause. Acquired heart diseases, such as fibrous scars (mainly post-myocarditis) and atheromatous coronary lesions, are less frequently involved. In this younger population, classical autopsy often fails to determine the cause in more than 40% of cases, leading to the term "sudden arrhythmic syndrome".

Few prospective studies have combined classical autopsy with systematic genetic analysis to identify the cause of SCA/SCD in the general young population, with no specific link to sports. One Australian study demonstrated the value of genetic testing, identifying a "clinically relevant" cardiac genetic variant for sudden death in 27% of cases. Moreover, the same pathology was identified in 13% of relatives of the victims who underwent clinical and genetic screening. Another small Swedish study (n=15), focusing specifically on channelopathies in cases of negative autopsies, revealed the disease in 40% of victims' families through genetic analysis.

Additionally, the role of acute or chronic toxic substance intake has been suggested, albeit without formal proof, as a factor promoting sports-related SCA/SCD. Toxicological screening is thus recommended as part of the etiological assessment. Including toxicological analysis alongside other etiological evaluations could help clarify the impact of illicit substances on sports-related SCA/SCD.

Justifications for the Study:

No prospective study has systematically combined the recommended hospital assessment in cases of successful resuscitation or the recommended medical autopsy in the event of death with global genetic and toxicological analyses in victims of sports-related SCA/SCD.

This combined approach is justified for several reasons. First, it would enhance our understanding of the etiologies of these events. Notably, so-called idiopathic left ventricular hypertrophy is found in more than 10% of sports-related SCD cases following classical autopsies. Further genetic exploration could help determine whether these anatomical forms are pathological. Additionally, many arrhythmic cardiac diseases are associated with an elevated risk of sports-related SCA/SCD. While arrhythmogenic right ventricular cardiomyopathy is well-documented, other forms of disease are characterized by areas of fibrosis or fatty infiltration in the myocardium, often due to genetic mutations affecting intercellular desmosomes. Comprehensive genetic testing, including whole exome sequencing, could clarify the contribution of various arrhythmogenic heart diseases to unexplained sports-related SCA/SCD.

Improving this knowledge will benefit ongoing discussions about enhancing the content and effectiveness of pre-participation screening for athletes. Moreover, identifying the cause of SCA/SCD is critical for the victims and their families. Understanding the cause may help families come to terms with the event and assist in preventing recurrence for successfully resuscitated individuals. Furthermore, since most hereditary heart diseases follow an autosomal dominant inheritance pattern, each first-degree relative has a 50% chance of carrying the same genetic mutation. Predictive testing, clinical assessment, and, if necessary, preventive treatment can be offered to these family members to reduce the risk of arrhythmic events.

Statistical Analysis:

Data analyses will be performed using specialized software, with a significance threshold set at 5%. Hypotheses will be formulated bilaterally.

A descriptive analysis of the collected population data will be conducted. Qualitative variables will be presented as numbers and percentages, while quantitative variables will be described using the mean, standard deviation, median, interquartile range, minimum, and maximum values.

For the primary analysis of the main outcome, the cause of sports-related SCA/SCD will be described in terms of numbers and percentages, along with the corresponding 95% confidence intervals.

For the secondary analyses, the judgment criteria, both overall and by vital status (survived or deceased), will be described in numbers and percentages, with 95% confidence intervals.

Being tested
Whole exome sequencing to detect myocardial genetic mutations (SCA group only)
Keywords
Sport related sudden cardiac arrest, Sport related sudden cardiac death, Young athlete, Etiological Diagnosis, Autopsy, Genetic, Toxicology, Hereditary Cardiac disease, Prevention
Medical subject headings
Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole exome sequencing to detect myocardial genetic mutations (SCA group only)Genetic

    Whole exome sequencing to detect myocardial genetic mutations

Study groups in NCT06642168
Study groupRoleWhat they receive
Victims of sport-related sudden cardiac arrest (SCA) : resuscitated SCA and non-resuscitated SCAFollowing 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.
Receives: Genetic: Whole exome sequencing to detect myocardial genetic mutations (SCA group only)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through study completion, approximately 39 months

Secondary outcomes (5)
  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.

    Measured: 3 to 6 months after the event

  2. 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.

    Measured: 3 to 6 months after the event

  3. 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.

    Measured: 24 to 30 months after the event

  4. 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.

    Measured: 3 to 6 months after the event

  5. Evaluation of the Familial Transmission of Hereditary Cardiovascular Pathologies Detected

    Results will be presented as the total number of cases (n) and the percentage of the total cases, with a 95% confidence interval.

    Measured: 3 to 12 months after the event.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start11 Oct 2024
  3. Primary completion11 Jan 2028 (estimated)
  4. Study completion11 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06642168
Sponsor's protocol ID
35RC19_8911_RESOUDRE
Acronym
RESOUDRE
Status last verified
Aug 2026
First submitted
8 Oct 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Sudden Cardiac Arrest and Sudden Cardiac Death, run by Rennes University Hospital at 26 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frédéric SCHNELL (0299284133, frederic.schnell@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of the Cause of Sports-Related Cardiorespiratory Arrest in a Young, Healthy Population (time frame: Through study completion, approximately 39 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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