- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593316
Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment (EXPLO-CCE)
Although the circumstances of onset and management of exertional heatstroke have been identified for several years, its pathophysiology remains imperfectly understood. Exertional heatstroke is the result of both extrinsic (i.e. environmental) and intrinsic (i.e. individual) contributing factors.
Extrinsic factors are well known (high ambient temperature and hygrometry, poorly "breathable" clothing, intense and prolonged physical effort) but some of them may be observed in milder conditions. In the French Armed Forces, 25% of the exertional heatstrokes that have been reported between 2005 and 2011 occurred below 17°C.
Intrinsic factors, on the other hand, are numerous and less consensual, partly because of the imperfect knowledge of exertional heatstroke physiopathology. Potential factors include a thermoregulatory defect (inability to maintain a temperature plateau during an effort) and several genetic mutations may also contribute to explain a propensity to present an exertional heatstroke. While exertional heatstroke is clearly not a monogenic pathology, the association of several polymorphisms could contribute to this vulnerability. Among the genes that have been explored, mutations in ryanodine receptor type 1 (RyR 1), calsequestrin-1 or angiotensin-1 converting enzyme (ACE) appear to be potential candidates. However, it is very likely that other polymorphisms may be involved, such as: genes involved in sports performance and exercise rhabdomyolysis, in the inflammatory cascade, permeability of the digestive epithelial barrier, adenosine receptors and susceptibility to anxiety.
Finally, motivation is a mixed factor often claimed to be involved in exertional heatstroke but has never been quantified and needs to be objectified.
To date, none of these hypotheses has been clearly assessed by comparing patients who experienced exertional heatstroke to healthy subjects.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Arnaud-Xavier JOUVION, MD
- Phone Number: +33 491617679
- Email: arnaud-xavier.jouvion@intradef.gouv.fr
Study Contact Backup
- Name: Keyne CHARLOT
- Phone Number: +33 178651303
- Email: keyne.charlot@intradef.gouv.fr
Study Locations
-
-
-
Brétigny-sur-Orge, France, 91223
- Not yet recruiting
- Institut de Recherche Biomédicale des Armées
-
Contact:
- Alexandra MALGOYRE, MD, PhD
- Phone Number: +33 178651317
- Email: alexandra.malgoyre@intradef.gouv.fr
-
Marseille, France, 13384
- Recruiting
- Hôpital d'Instruction des Armées Laveran
-
Contact:
- Arnaud-Xavier JOUVION, MD
- Phone Number: +33 491617679
- Email: arnaud-xavier.jouvion@intradef.gouv.fr
-
Paris, France, 75005
- Not yet recruiting
- Ecole du Val-de-Grâce
-
Contact:
- Alexandra MALGOYRE, MD, PhD
- Phone Number: +33 178651317
- Email: alexandra.malgoyre@intradef.gouv.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Active military
- Between 18 and 45 years old
- Ability to the walk/run test
Exclusion Criteria:
- Ongoing drug treatment (for the control group only),
- BMI greater than or equal to 30,
- Contraindication to the ingestion of a core temperature capsule
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Exertional heatstroke group
Patients presenting or having presented exertional heatstroke.
|
A saliva sample will be collected before physical exercise.
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
The participant will perform a walk/run test.
Heart rate will be monitored during physical exercise thanks to a chest belt.
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
|
Control group
Healthy people who never experienced exertional heatstroke.
|
A saliva sample will be collected before physical exercise.
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
The participant will perform a walk/run test.
Heart rate will be monitored during physical exercise thanks to a chest belt.
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of the frequency of CYP24A1 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of CYP24A1 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of DRD2 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of DRD2 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of BDNF gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of BDNF gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of COMT gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of COMT gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of FAAH gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of FAAH gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of TPH2 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of TPH2 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of GRIN2B gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of GRIN2B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of PER3 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of PER3 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of TNF-a gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of TNF-a gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of IL-6 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of IL-6 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of IL1B gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of IL1B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of HSPA1B gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of HSPA1B gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Difference of the frequency of TLR4 gene polymorphisms between the heatstroke group and the control group
Time Frame: At enrollment (day 1)
|
The frequency of TLR4 gene polymorphisms will calculated in each group by dividing the number of participants who present the polymorphism by the total number of participants in the group.
|
At enrollment (day 1)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019PBMD03
- 2020-A01967-32 (Other Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heat Stroke
-
Erasmus Medical CenterRecruitingHeat Illness | Heat Exhaustion | Heat Stroke ExertionalNetherlands
-
Eagle Pharmaceuticals, Inc.CompletedExertional Heat StrokeSaudi Arabia
-
Johns Hopkins UniversityAga Khan University; Aman FoundationCompletedHeat Illness | Heat | Heat Exposure | Heat Stroke | Heat Exhaustion | Heat Syncope, Sequela | Heat Collapse | Heat Stroke and SunstrokePakistan
-
Stanford UniversityCompleted
-
Cairo UniversityRecruitingHeat Stress Disorders | Heat Stroke | Heat Exhaustion | Heat CrampsEgypt
-
Sheba Medical CenterCompletedHealthy | Heat StrokeIsrael
-
Second Affiliated Hospital, School of Medicine,...Jinhua People's Hospital; Jinhua Municipal Central Hospital; Yiwu Central Hospital and other collaboratorsRecruiting
-
Direction Centrale du Service de Santé des ArméesRecruiting
-
Eagle Pharmaceuticals, Inc.Quintiles, Inc.Completed
-
Second Affiliated Hospital, School of Medicine,...Jinhua People's Hospital; Jinhua Municipal Central Hospital; Yiwu Central Hospital and other collaboratorsRecruiting
Clinical Trials on Saliva collection
-
Fondazione Don Carlo Gnocchi OnlusAzienda Ospedaliero Universitaria di CagliariRecruitingParkinson's Disease and ParkinsonismItaly
-
Quadram Institute BioscienceGlaxoSmithKlineCompleted
-
Aydin Adnan Menderes UniversityCompleted
-
Instituto do Cancer do Estado de São PauloInstituto de Ciências Biomédicas da Universidade de São PauloNot yet recruitingOral Squamous Cell Carcinoma (OSCC)Brazil
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Aydin Adnan Menderes UniversityCompleted
-
Rennes University HospitalCompletedAcute Respiratory Distress Syndrome | SARS-CoV-2 CoronavirusFrance
-
Unity Health TorontoCompleted
-
GlaxoSmithKlineCompletedInfections, CytomegalovirusFinland, United States, Mexico