Heat StrokeEXPLO-CCENCT04593316
Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment
An observational study of Heat Stroke, run by Direction Centrale du Service de Santé des Armées at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke
- What is being tested?
- Saliva collection, Questionnaires and Ingestible core temperature capsule intake
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Nov 2020to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will be composed of patients who are experiencing or who have experienced exertional heatstroke (heatstroke group) and people who have not (control group).
Who may be able to join
- Active military
- Between 18 and 45 years old
- Ability to the walk/run test
Who cannot join
- Ongoing drug treatment (for the control group only),
- BMI greater than or equal to 30,
- Contraindication to the ingestion of a core temperature capsule
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Institut de Recherche Biomédicale des Armées
Brétigny-sur-Orge, 91223
Alexandra MALGOYRE, MD, PhD, 178651317 ext. +33, alexandra.malgoyre@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Laveran
Marseille, 13384
Arnaud-Xavier JOUVION, MD, 491617679 ext. +33, arnaud-xavier.jouvion@intradef.gouv.fr
- Not yet recruiting
Ecole du Val-de-Grâce
Paris, 75005
Alexandra MALGOYRE, MD, PhD, 178651317 ext. +33, alexandra.malgoyre@intradef.gouv.fr
About this study
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.
Read more
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.
- Conditions
- Heat Stroke
- Being tested
- Saliva collection, Questionnaires, Ingestible core temperature capsule intake, Physical exercise, Heart rate monitoring
- Medical subject headings
- Heat Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
A saliva sample will be collected before physical exercise.
QuestionnairesBehavioural
The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
Ingestible core temperature capsule intakeOther
The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
Physical exerciseOther
The participant will perform a walk/run test.
Heart rate monitoringOther
Heart rate will be monitored during physical exercise thanks to a chest belt.
Core temperature monitoringOther
Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
| Study group | Role | What they receive |
|---|---|---|
| Exertional heatstroke group | Patients presenting or having presented exertional heatstroke. Receives: Other: Saliva collection; Behavioral: Questionnaires; Other: Ingestible core temperature capsule intake; Other: Physical exercise; Other: Heart rate monitoring; Other: Core temperature monitoring | |
| Control group | Healthy people who never experienced exertional heatstroke. Receives: Other: Saliva collection; Behavioral: Questionnaires; Other: Ingestible core temperature capsule intake; Other: Physical exercise; Other: Heart rate monitoring; Other: Core temperature monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the frequency of CYP24A1 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of DRD2 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of BDNF gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of COMT gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of FAAH gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of TPH2 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of GRIN2B gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of PER3 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of TNF-a gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of IL-6 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of IL1B gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of HSPA1B gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Difference of the frequency of TLR4 gene polymorphisms between the heatstroke group and the control group
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.
Measured: At enrollment (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start2 Nov 2020
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593316
- Sponsor's protocol ID
- 2019PBMD03
- Other IDs
- 2020-A01967-32
- Acronym
- EXPLO-CCE
- Status last verified
- Mar 2021
- First submitted
- 13 Oct 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Risk Factors for the Occurrence and Severity of Exertional Heatstroke in the Military Environment
- ClinicalTrials.gov ID
- NCT04593316
- Acronym / sponsor ID
- EXPLO-CCE / 2019PBMD03
- Conditions
- Heat Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exertional heatstroke group | – | Other: Saliva collection, Behavioral: Questionnaires, Other: Ingestible core temperature capsule intake, Other: Physical exercise, Other: Heart rate monitoring, Other: Core temperature monitoringPatients presenting or having presented exertional heatstroke. |
| Control group | – | Other: Saliva collection, Behavioral: Questionnaires, Other: Ingestible core temperature capsule intake, Other: Physical exercise, Other: Heart rate monitoring, Other: Core temperature monitoringHealthy people who never experienced exertional heatstroke. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be composed of patients who are experiencing or who have experienced exertional heatstroke (heatstroke group) and people who have not (control group).
Key inclusion criteria (3 listed)
- Active military
- Between 18 and 45 years old
- Ability to the walk/run test
Key exclusion criteria (3 listed)
- Ongoing drug treatment (for the control group only),
- BMI greater than or equal to 30,
- Contraindication to the ingestion of a core temperature capsule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collectionA saliva sample will be collected before physical exercise. | Other | Control group, Exertional heatstroke group |
| QuestionnairesThe participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise. | Behavioural | Control group, Exertional heatstroke group |
| Ingestible core temperature capsule intakeThe participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise. | Other | Control group, Exertional heatstroke group |
| Physical exerciseThe participant will perform a walk/run test. | Other | Control group, Exertional heatstroke group |
| Heart rate monitoringHeart rate will be monitored during physical exercise thanks to a chest belt. | Other | Control group, Exertional heatstroke group |
| Core temperature monitoringHeart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule. | Other | Control group, Exertional heatstroke group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stroke, run by Direction Centrale du Service de Santé des Armées at 3 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud-Xavier JOUVION, MD (491617679 ext. +33, arnaud-xavier.jouvion@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the frequency of CYP24A1 gene polymorphisms between the heatstroke group and the control group (time frame: At enrollment (day 1)). The study lists 13 primary outcomes in all. 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 9 Mar 2021.