Clinical trial NCT01577576: Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes
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 Calcifications
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Monckeberg Medial Calcific Sclerosis
Keywords: Athletes
Sedentary volunteers
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of three groups of healthy volunteers: (1) high impact lower-limb sports (marathon or trail); (2) low-impact lower-limb sports and (3) sedentary volunteers. All volunteers are between the ages of 25 and 40.

The groups will be matched by age and sex. Athletic groups will be matched according to years of intensive practice and hours of training.

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).

Eligibility criteria: Inclusion Criteria for athletic and sedentary volunteers:

* The volunteer must have given his/her informed and signed consent
* The volunteer must be insured or beneficiary of a health insurance plan
* Volunteers without cardiovascular disease, glucose regulation disorders or known renal disease

Inclusion Criteria for athletic volunteers only:

* Ongoing athletic activity for the past 10 years
* Athletic activity at the regional level for the past 5 years
* Practices one of the three following sports: marathon, trail running, cycling.

Exclusion Criteria for athletic and sedentary volunteers:

* The volunteer is participating in another study
* The volunteer is in an exclusion period determined by a previous study
* The volunteer is under judicial protection, under tutorship or curatorship
* The volunteer refuses to sign the consent
* It is impossible to correctly inform the volunteer
* The volunteer is pregnant, parturient, or breastfeeding
* Tobacco use
* Contraindications for the practice of physical activity (joint, heart or other)
* Intercurrent pathology
* First degree family history of cardiovascular disease
* Known dyslipidemia (including cholesterol)
* Glucose tolerance abnormalities (prediabetes or diabetes)
* Treatment with certain drugs used for treating erectile dysfunction: Sildefanil (Viagra), Tadalafil (Cialis), Vardenafil (Levitra) and yohimbine (Yohimbine Houde and Yocoral)

Exclusion Criteria for sedentary volunteers only:

* More than two hours of athletic activity per week
* History of intense athletic training
* Body mass index \>= 25 kg/m\^2

Primary outcomes:
measure: Presence / absence of intra parietal calcification of lower limb arteries
timeFrame: Baseline (Day 0; transversal study)
Secondary outcomes:
measure: Extent of intra parietal calcification of lower limb arteries
timeFrame: Baseline (Day 0; transversal study)
measure: Inner diameter of the intima-media of the common femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Outer diameter of the intima-media of the common femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Inner diameter of the intima-media of the superficial femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Outer diameter of the intima-media of the superficial femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Inner diameter of the intima-media of the common carotid artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Outer diameter of the intima-media of the common carotid artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Thickness of the intima-media of the common femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Thickness of the intima-media of the superficial femoral artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Thickness of the intima-media of the common carotid artery (mm)
timeFrame: Baseline (Day 0; transversal study)
measure: Local parietal compliance of the superficial femoral artery
timeFrame: Baseline (Day 0; transversal study)
measure: Compliance of the carotid artery
timeFrame: Baseline (Day 0; transversal study)
measure: Distensibility of the carotid artery
timeFrame: Baseline (Day 0; transversal study)
measure: Arterial wave velocity in lower limb
timeFrame: Baseline (Day 0; transversal study)
measure: Arterial wave velocity in upper limb
timeFrame: Baseline (Day 0; transversal study)
measure: Endothelium-dependent vasorelaxation in the femoral artery
timeFrame: Baseline (Day 0; transversal study)
measure: Postischemic vasomotor response at the (skin) microcirculatory level
timeFrame: Baseline (Day 0; transversal study)
measure: Systolic pressure index at the ankle
timeFrame: Baseline (Day 0; transversal study)
measure: Systolic pressure index for the big toe
timeFrame: Baseline (Day 0; transversal study)
measure: Cardiac afterload index
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: the stroke volume
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: cardiac output
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: peripheral vascular resistance
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: fractional shortening
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing systolic function: global longitudinal strain
timeFrame: Baseline (Day 0; transversal study)
measure: Ventricular-arterial coupling
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler
timeFrame: Baseline (Day 0; transversal study)
measure: Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate
timeFrame: Baseline (Day 0; transversal study)
measure: Years of athletic training
timeFrame: Baseline (Day 0; transversal study)
measure: Hours of athletic training per week
timeFrame: Baseline (Day 0; transversal study)
measure: Best performance in the last 6 months
timeFrame: Baseline (Day 0; transversal study)
measure: Lower limb muscle mass
timeFrame: Baseline (Day 0; transversal study)
measure: Bone density
timeFrame: Baseline (Day 0; transversal study)
measure: Dietary protein intake
timeFrame: Baseline (Day 0; transversal study)
measure: Dietary protein intake
timeFrame: Baseline (Day 0; transversal study)
measure: Dietary calcium intake
timeFrame: Baseline (Day 0; transversal study)
measure: Serum protein
timeFrame: Baseline (Day 0; transversal study)
measure: Serum calcium
timeFrame: Baseline (Day 0; transversal study)
measure: Serum phosphorus
timeFrame: Baseline (Day 0; transversal study)
measure: Serum parathyroid hormone
timeFrame: Baseline (Day 0; transversal study)
measure: Serum vitamin D2
timeFrame: Baseline (Day 0; transversal study)
measure: Serum vitamin D3
timeFrame: Baseline (Day 0; transversal study)
Other outcomes:
Locations:
city: Avignon
country: France
facility: Université d'Avignon, Faculté des Sciences
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Antonia Perez Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: