Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes
- Conditions
- Monckeberg Medial Calcific Sclerosis
- Registration Number
- NCT01577576
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- 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 Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence / absence of intra parietal calcification of lower limb arteries Baseline (Day 0; transversal study)
- Secondary Outcome Measures
Name Time Method Serum vitamin D2 Baseline (Day 0; transversal study) µg/l
Extent of intra parietal calcification of lower limb arteries Baseline (Day 0; transversal study) Score ranging from 0 to 3
Inner diameter of the intima-media of the superficial femoral artery (mm) Baseline (Day 0; transversal study) Outer diameter of the intima-media of the superficial femoral artery (mm) Baseline (Day 0; transversal study) Inner diameter of the intima-media of the common carotid artery (mm) Baseline (Day 0; transversal study) Inner diameter of the intima-media of the common femoral artery (mm) Baseline (Day 0; transversal study) Outer diameter of the intima-media of the common femoral artery (mm) Baseline (Day 0; transversal study) Outer diameter of the intima-media of the common carotid artery (mm) Baseline (Day 0; transversal study) Thickness of the intima-media of the common femoral artery (mm) Baseline (Day 0; transversal study) Thickness of the intima-media of the superficial femoral artery (mm) Baseline (Day 0; transversal study) Thickness of the intima-media of the common carotid artery (mm) Baseline (Day 0; transversal study) Local parietal compliance of the superficial femoral artery Baseline (Day 0; transversal study) mm\^2/mmHg
Compliance of the carotid artery Baseline (Day 0; transversal study) mm\^2/mmHg
Distensibility of the carotid artery Baseline (Day 0; transversal study) mmHg\^-1\*10\^-2
Arterial wave velocity in upper limb Baseline (Day 0; transversal study) m/s
Endothelium-dependent vasorelaxation in the femoral artery Baseline (Day 0; transversal study) Postischemic vasomotor response at the (skin) microcirculatory level Baseline (Day 0; transversal study) Systolic pressure index at the ankle Baseline (Day 0; transversal study) relative units
Cardiac afterload index Baseline (Day 0; transversal study) g/cm\^2
Arterial wave velocity in lower limb Baseline (Day 0; transversal study) m/s
Systolic pressure index for the big toe Baseline (Day 0; transversal study) relative units
Echocardiographic parameters analyzing systolic function: the stroke volume Baseline (Day 0; transversal study) ml
Echocardiographic parameters analyzing systolic function: cardiac output Baseline (Day 0; transversal study) l/min
Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate Baseline (Day 0; transversal study) s\^-1
Echocardiographic parameters analyzing systolic function: peripheral vascular resistance Baseline (Day 0; transversal study) Pa.s/m\^3
Echocardiographic parameters analyzing systolic function: fractional shortening Baseline (Day 0; transversal study) Echocardiographic parameters analyzing systolic function: global longitudinal strain Baseline (Day 0; transversal study) Ventricular-arterial coupling Baseline (Day 0; transversal study) relative units
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity Baseline (Day 0; transversal study) cm/s
Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler Baseline (Day 0; transversal study) cm.s-1
Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity Baseline (Day 0; transversal study) cm/s
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity Baseline (Day 0; transversal study) relative units
Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler Baseline (Day 0; transversal study) cm/s
Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler Baseline (Day 0; transversal study) cm/s
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler Baseline (Day 0; transversal study) relative units
Years of athletic training Baseline (Day 0; transversal study) Best performance in the last 6 months Baseline (Day 0; transversal study) Hours of athletic training per week Baseline (Day 0; transversal study) h/week
Lower limb muscle mass Baseline (Day 0; transversal study) g
Bone density Baseline (Day 0; transversal study) g/cm\^2
Dietary calcium intake Baseline (Day 0; transversal study) mg/day
Dietary protein intake Baseline (Day 0; transversal study) % calories per day
Serum protein Baseline (Day 0; transversal study) g/l
Serum parathyroid hormone Baseline (Day 0; transversal study) ng/l
Serum calcium Baseline (Day 0; transversal study) mmol/l
Serum phosphorus Baseline (Day 0; transversal study) mmol/l
Serum vitamin D3 Baseline (Day 0; transversal study) µg/l
Trial Locations
- Locations (2)
Université d'Avignon, Faculté des Sciences
🇫🇷Avignon, France
CHU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France