An observational study in Heat Stroke, sponsored by Direction Centrale du Service de Santé des Armées. Status unknown at 3 sites in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Direction Centrale du Service de Santé des Armées · Observational
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.
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
Browse Heat Stroke studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients presenting or having presented exertional heatstroke.
Other: Saliva collection · Behavioral: Questionnaires · Other: Ingestible core temperature capsule intake · Other: Physical exercise · Other: Heart rate monitoring · Other: Core temperature monitoring
Healthy people who never experienced exertional heatstroke.
Other: Saliva collection · Behavioral: Questionnaires · Other: Ingestible core temperature capsule intake · Other: Physical exercise · Other: Heart rate monitoring · Other: Core temperature monitoring
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At enrollment (day 1)
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Direction Centrale du Service de Santé des Armées