Clinical Trial: Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Morphological, Biomechanical and Functional Properties of the Arterial Wall of Athletes: Impact and Consequences of Mechanical Stress on the Cardiovascular Adaptations of Peripheral Arterial Calcifica

Brief Summary: The main objective of this study is to obtain data for the integrated analysis of morphological, functional and biomechanical parameters pertaining to lower limb arteries in various categories of elite athletes (without cardiovascular risk and practicing high- or low-impact aerobic activities which preferentially implicate lower limb activity) as compared to (each other and to) sedentary controls.

Detailed Summary:

Secondary objectives of this study are:

A. Determine the presence and extent of intima-media calcifications in athletes B. Determine the relationship between these calcifications and the level, length and intensity of sports activity.

C. Determine the relationship between these properties and calcification of the arterial wall D. Analyze the relationship between the type of sports activity and properties of the arterial wall.

E. Examine the relationship between the properties of the arterial wall and peripheral perfusion pressures.

F. Examine the relationship between the properties of the arterial wall, changes in afterload, morphology and systolic heart function.

G. Analyze the relationships between the parameters characterizing the arterial wall and muscle mass of the lower limbs.

H. Analyze the relationship between the presence of intramural calcification and bone density determined by densitometry.

I. Analyze the relationship between the presence of intramural calcification and dietary protein intake and calcium.

J. Compare indices of pressure at the ankle and toe, depending on the extent of calcification.

K. Create a collection of biological samples (serum).


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: Presence / absence of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Extent of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ]
    Score ranging from 0 to 3
  • Inner diameter of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Outer diameter of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Inner diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Outer diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Inner diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Outer diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Thickness of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Thickness of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Thickness of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
  • Local parietal compliance of the superficial femoral artery [ Time Frame: Baseline (Day 0; transversal study) ]
    mm^2/mmHg
  • Compliance of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ]
    mm^2/mmHg
  • Distensibility of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ]
    mmHg^-1*10^-2
  • Arterial wave velocity in lower limb [ Time Frame: Baseline (Day 0; transversal study) ]
    m/s
  • Arterial wave velocity in upper limb [ Time Frame: Baseline (Day 0; transversal study) ]
    m/s
  • Endothelium-dependent vasorelaxation in the femoral artery [ Time Frame: Baseline (Day 0; transversal study) ]
  • Postischemic vasomotor response at the (skin) microcirculatory level [ Time Frame: Baseline (Day 0; transversal study) ]
  • Systolic pressure index at the ankle [ Time Frame: Baseline (Day 0; transversal study) ]
    relative units
  • Systolic pressure index for the big toe [ Time Frame: Baseline (Day 0; transversal study) ]
    relative units
  • Cardiac afterload index [ Time Frame: Baseline (Day 0; transversal study) ]
    g/cm^2
  • Echocardiographic parameters analyzing systolic function: the stroke volume [ Time Frame: Baseline (Day 0; transversal study) ]
    ml
  • Echocardiographic parameters analyzing systolic function: cardiac output [ Time Frame: Baseline (Day 0; transversal study) ]
    l/min
  • Echocardiographic parameters analyzing systolic function: peripheral vascular resistance [ Time Frame: Baseline (Day 0; transversal study) ]
    Pa.s/m^3
  • Echocardiographic parameters analyzing systolic function: fractional shortening [ Time Frame: Baseline (Day 0; transversal study) ]
  • Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ]
    cm.s-1
  • Echocardiographic parameters analyzing systolic function: global longitudinal strain [ Time Frame: Baseline (Day 0; transversal study) ]
  • Ventricular-arterial coupling [ Time Frame: Baseline (Day 0; transversal study) ]
    relative units
  • Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity [ Time Frame: Baseline (Day 0; transversal study) ]
    cm/s
  • Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity [ Time Frame: Baseline (Day 0; transversal study) ]
    cm/s
  • Echocardiographic parameters analyzing diastolic function: transmitr

    Original Secondary Outcome:

    • Extent of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ]
      Score ranging from 0 to 3
    • Inner diameter of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Outer diameter of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Inner diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Outer diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Inner diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Outer diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Thickness of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Thickness of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Thickness of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ]
    • Local parietal compliance of the superficial femoral artery [ Time Frame: Baseline (Day 0; transversal study) ]
      mm^2/mmHg
    • Compliance of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ]
      mm^2/mmHg
    • Distensibility of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ]
      mmHg^-1*10^-2
    • Arterial wave velocity in lower limb [ Time Frame: Baseline (Day 0; transversal study) ]
      m/s
    • Arterial wave velocity in upper limb [ Time Frame: Baseline (Day 0; transversal study) ]
      m/s
    • Endothelium-dependent vasorelaxation in the femoral artery [ Time Frame: Baseline (Day 0; transversal study) ]
      %
    • Postischemic vasomotor response at the (skin) microcirculatory level [ Time Frame: Baseline (Day 0; transversal study) ]
      %
    • Systolic pressure index at the ankle [ Time Frame: Baseline (Day 0; transversal study) ]
      relative units
    • Systolic pressure index for the big toe [ Time Frame: Baseline (Day 0; transversal study) ]
      relative units
    • Cardiac afterload index [ Time Frame: Baseline (Day 0; transversal study) ]
      g/cm^2
    • Echocardiographic parameters analyzing systolic function: the stroke volume [ Time Frame: Baseline (Day 0; transversal study) ]
      ml
    • Echocardiographic parameters analyzing systolic function: cardiac output [ Time Frame: Baseline (Day 0; transversal study) ]
      l/min
    • Echocardiographic parameters analyzing systolic function: peripheral vascular resistance [ Time Frame: Baseline (Day 0; transversal study) ]
      Pa.s/m^3
    • Echocardiographic parameters analyzing systolic function: fractional shortening [ Time Frame: Baseline (Day 0; transversal study) ]
      %
    • Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ]
      cm.s-1
    • Echocardiographic parameters analyzing systolic function: global longitudinal strain [ Time Frame: Baseline (Day 0; transversal study) ]
      %
    • Ventricular-arterial coupling [ Time Frame: Baseline (Day 0; transversal study) ]
      relative units
    • Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity [ Time Frame: Baseline (Day 0; transversal study) ]
      cm/s
    • Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity [ Time Fram

      Information By: Centre Hospitalier Universitaire de Nīmes

      Dates:
      Date Received: April 12, 2012
      Date Started: September 2012
      Date Completion:
      Last Updated: November 27, 2015
      Last Verified: November 2015