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出境医 / 临床实验 / Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains (UTMB_2019)

Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains (UTMB_2019)

Study Description
Brief Summary:

Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory.

The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that:

  • A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that,
  • Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race.

According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.


Condition or disease Intervention/treatment Phase
Ultra-marathon Runners Other: Neuromuscular tests in isometric mode Device: Transcranial Magnetic Stimulation (TMS) Other: Neuromuscular fatigue assessment test Other: treadmill Biological: Blood sample Biological: Urinary sample Not Applicable

Detailed Description:
Thus, the main purpose of the present project is to investigate whether sex differences in neuromuscular fatigue in plantar flexors depend on the distance (> 100 km vs < 60 km).
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
Actual Study Start Date : July 2, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: female subjects involved in races over 100 km (F>100)
Female subjects involved in races over 100 km (F>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)

Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).

Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.

Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.

Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.

Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

Experimental: female subjects involved in races less than 60 km (F<60)
Female subjects involved in races less than 60 km (F<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)

Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).

Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.

Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.

Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.

Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

Experimental: male subjects involved in races over 100 km (H>100)
Male subjects involved in races over 100 km (H>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)

Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).

Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.

Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.

Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.

Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

Experimental: male subjects involved in races less than 60 km (H<60)
Male subjects involved in races less than 60 km (H<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
Other: Neuromuscular tests in isometric mode

Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

  • Voluntary maximum forces plantar flexors and knee extensors
  • Electrically evoked forces
  • ElectroMyoGraphic activity (EMG)
  • Three-Modality Evoked Potentials (TMEPs)

Device: Transcranial Magnetic Stimulation (TMS)
Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).

Other: Neuromuscular fatigue assessment test
Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.

Other: treadmill
2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.

Biological: Blood sample
Blood sample will be realized to measure hemorrheologic and hematologic parameters.

Biological: Urinary sample
Urinary sample will be realized to measure hemorrheologic and hematologic parameters.

Outcome Measures
Primary Outcome Measures :
  1. Variation (%) of the amplitudes of the electric shock [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors


Secondary Outcome Measures :
  1. Voluntary maximum forces plantar flexors [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Measured by voluntary maximum forces plantar flexors test (seat type Cybex) in percentage (%).


  2. Voluntary maximum forces knee extensors [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Voluntary maximum forces knee extensors measures by seat type Cybex in percentage (%).


  3. Electrically evoked forces [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Electrically evoked forces measures by neurostimulator in percentage (%).


  4. ElectroMyoGraphic activity (EMG) [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    ElectroMyoGraphic activity (EMG) measures by electromyography. The EMG signal will be recorded with pairs of electrodes fixed with an adhesive tape bilaterally over the muscular belly.


  5. Three-Modality Evoked Potentials (TMEPs) [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Three-Modality Evoked Potentials (TMEPs) measures by magnetic stimulator in percentage (%).


  6. Transcranial Magnetic Stimulation (TMS) [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis :

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Measured supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS) in percentage (%).


  7. Force/Velocity Profile (FVP) [ Time Frame: 5 or 6 day before the race and 1 hour after ]

    Analysis:

    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.

    Measured Force/Velocity Profile (FVP) test: 2 sprints of 8 seconds on a cycle ergometer.


  8. Blood viscosity [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  9. Number of red blood cell [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  10. Number of platelets [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  11. Number of white blood cells [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  12. Rate of hemoglobin (%) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  13. creatinine (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  14. C reactive protein (CRP) (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  15. urea (g/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  16. uric acid (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  17. lactate (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.

  18. Proteinuria-density urinary (mg/24h) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by urinary sample.

  19. Kinematic variable [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by treadmill result.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject listed in the race "2019 Mont Blanc Ultra Trail"
  • Affiliates or beneficiaries of social security scheme
  • Signed consent

Exclusion Criteria:

  • Subject having been injured in the previous 3 months
  • Pregnant woman
  • Chronic joint diseases
  • Chronic or central neurological pathologies
  • Taking neuroactive substances that can alter corticospinal excitability
  • Contraindication to experimental procedures including Transcranial Magnetic Stimulation (TMS)
  • Taking corticosteroids in the previous 3 months
Contacts and Locations

Locations
Layout table for location information
France
CHU Saint-Etienne
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Léonard FEASSON, MD PhD CHU SAINT-ETIENNE
Study Director: Guillaume MILLET, PhD University of Saint-Etienne
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE July 2, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
Variation (%) of the amplitudes of the electric shock [ Time Frame: 5 or 6 day before the race and 1 hour after ]
Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
Variation (%) of the amplitudes of the electric shock [ Time Frame: 5 or 6 day before the race and 1 hour after ]
Comparison of variation in the plantar flexor peripheral peak twitch between males and females depending on the distance of the race. Measured by the electrically evoked force after contraction in isometric mode of the plantar flexors
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Voluntary maximum forces plantar flexors [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Measured by voluntary maximum forces plantar flexors test (seat type Cybex) in percentage (%).
  • Voluntary maximum forces knee extensors [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Voluntary maximum forces knee extensors measures by seat type Cybex in percentage (%).
  • Electrically evoked forces [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Electrically evoked forces measures by neurostimulator in percentage (%).
  • ElectroMyoGraphic activity (EMG) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    ElectroMyoGraphic activity (EMG) measures by electromyography. The EMG signal will be recorded with pairs of electrodes fixed with an adhesive tape bilaterally over the muscular belly.
  • Three-Modality Evoked Potentials (TMEPs) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Three-Modality Evoked Potentials (TMEPs) measures by magnetic stimulator in percentage (%).
  • Transcranial Magnetic Stimulation (TMS) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis :
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Measured supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS) in percentage (%).
  • Force/Velocity Profile (FVP) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Analysis:
    • Quantification of neuromuscular fatigue assessment;
    • Evolution of race mechanics and the energy cost between males and females depending on the distance of the race.
    Measured Force/Velocity Profile (FVP) test: 2 sprints of 8 seconds on a cycle ergometer.
  • Blood viscosity [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • Number of red blood cell [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • Number of platelets [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • Number of white blood cells [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • Rate of hemoglobin (%) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • creatinine (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • C reactive protein (CRP) (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • urea (g/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • uric acid (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • lactate (mg/L) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by blood sample.
  • Proteinuria-density urinary (mg/24h) [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by urinary sample.
  • Kinematic variable [ Time Frame: 5 or 6 day before the race and 1 hour after ]
    Measured by treadmill result.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
Official Title  ICMJE Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains
Brief Summary

Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory.

The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that:

  • A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that,
  • Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race.

According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.

Detailed Description Thus, the main purpose of the present project is to investigate whether sex differences in neuromuscular fatigue in plantar flexors depend on the distance (> 100 km vs < 60 km).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Ultra-marathon Runners
Intervention  ICMJE
  • Other: Neuromuscular tests in isometric mode

    Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :

    • Voluntary maximum forces plantar flexors and knee extensors
    • Electrically evoked forces
    • ElectroMyoGraphic activity (EMG)
    • Three-Modality Evoked Potentials (TMEPs)
  • Device: Transcranial Magnetic Stimulation (TMS)
    Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
  • Other: Neuromuscular fatigue assessment test
    Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
  • Other: treadmill
    2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
  • Biological: Blood sample
    Blood sample will be realized to measure hemorrheologic and hematologic parameters.
  • Biological: Urinary sample
    Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
Study Arms  ICMJE
  • Experimental: female subjects involved in races over 100 km (F>100)
    Female subjects involved in races over 100 km (F>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
    Interventions:
    • Other: Neuromuscular tests in isometric mode
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Other: Neuromuscular fatigue assessment test
    • Other: treadmill
    • Biological: Blood sample
    • Biological: Urinary sample
  • Experimental: female subjects involved in races less than 60 km (F<60)
    Female subjects involved in races less than 60 km (F<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
    Interventions:
    • Other: Neuromuscular tests in isometric mode
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Other: Neuromuscular fatigue assessment test
    • Other: treadmill
    • Biological: Blood sample
    • Biological: Urinary sample
  • Experimental: male subjects involved in races over 100 km (H>100)
    Male subjects involved in races over 100 km (H>100) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
    Interventions:
    • Other: Neuromuscular tests in isometric mode
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Other: Neuromuscular fatigue assessment test
    • Other: treadmill
    • Biological: Blood sample
    • Biological: Urinary sample
  • Experimental: male subjects involved in races less than 60 km (H<60)
    Male subjects involved in races less than 60 km (H<60) will be included. They will have neuromuscular tests in isometric mode, Transcranial Magnetic Stimulation (TMS), neuromuscular fatigue assessment test, treadmill, blood sample and urinary sample.
    Interventions:
    • Other: Neuromuscular tests in isometric mode
    • Device: Transcranial Magnetic Stimulation (TMS)
    • Other: Neuromuscular fatigue assessment test
    • Other: treadmill
    • Biological: Blood sample
    • Biological: Urinary sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
75
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
86
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject listed in the race "2019 Mont Blanc Ultra Trail"
  • Affiliates or beneficiaries of social security scheme
  • Signed consent

Exclusion Criteria:

  • Subject having been injured in the previous 3 months
  • Pregnant woman
  • Chronic joint diseases
  • Chronic or central neurological pathologies
  • Taking neuroactive substances that can alter corticospinal excitability
  • Contraindication to experimental procedures including Transcranial Magnetic Stimulation (TMS)
  • Taking corticosteroids in the previous 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025138
Other Study ID Numbers  ICMJE 19CH060
2019-A00736-51 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Léonard FEASSON, MD PhD CHU SAINT-ETIENNE
Study Director: Guillaume MILLET, PhD University of Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP