Brief 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. 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Nov 2020

Longer than P75 for all trials

Geographic Reach

1 country

3 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

First Submitted

Initial submission to the registry

October 13, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed

13 days until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed

Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

October 13, 2020

Last Update Submit

March 8, 2021

Conditions

Heat Stroke

Outcome Measures

Primary Outcomes (13)

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
At enrollment (day 1)

Study Arms (2)

Exertional heatstroke group

Patients presenting or having presented exertional heatstroke.

Other: Saliva collectionBehavioral: QuestionnairesOther: Ingestible core temperature capsule intakeOther: Physical exerciseOther: Heart rate monitoringOther: Core temperature monitoring

Control group

Healthy people who never experienced exertional heatstroke.

Other: Saliva collectionBehavioral: QuestionnairesOther: Ingestible core temperature capsule intakeOther: Physical exerciseOther: Heart rate monitoringOther: Core temperature monitoring