Monckeberg Medial Calcific Sclerosis Clinical Trial
— MediaSportOfficial 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
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.
| Status | Terminated |
| Enrollment | 56 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 25 Years to 40 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| France | Université d'Avignon, Faculté des Sciences | Avignon | |
| France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Presence / absence of intra parietal calcification of lower limb arteries | Baseline (Day 0; transversal study) | No | |
| Secondary | Extent of intra parietal calcification of lower limb arteries | Score ranging from 0 to 3 | Baseline (Day 0; transversal study) | No |
| Secondary | Inner diameter of the intima-media of the common femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Outer diameter of the intima-media of the common femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Inner diameter of the intima-media of the superficial femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Outer diameter of the intima-media of the superficial femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Inner diameter of the intima-media of the common carotid artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Outer diameter of the intima-media of the common carotid artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Thickness of the intima-media of the common femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Thickness of the intima-media of the superficial femoral artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Thickness of the intima-media of the common carotid artery (mm) | Baseline (Day 0; transversal study) | No | |
| Secondary | Local parietal compliance of the superficial femoral artery | mm^2/mmHg | Baseline (Day 0; transversal study) | No |
| Secondary | Compliance of the carotid artery | mm^2/mmHg | Baseline (Day 0; transversal study) | No |
| Secondary | Distensibility of the carotid artery | mmHg^-1*10^-2 | Baseline (Day 0; transversal study) | No |
| Secondary | Arterial wave velocity in lower limb | m/s | Baseline (Day 0; transversal study) | No |
| Secondary | Arterial wave velocity in upper limb | m/s | Baseline (Day 0; transversal study) | No |
| Secondary | Endothelium-dependent vasorelaxation in the femoral artery | Baseline (Day 0; transversal study) | No | |
| Secondary | Postischemic vasomotor response at the (skin) microcirculatory level | Baseline (Day 0; transversal study) | No | |
| Secondary | Systolic pressure index at the ankle | relative units | Baseline (Day 0; transversal study) | No |
| Secondary | Systolic pressure index for the big toe | relative units | Baseline (Day 0; transversal study) | No |
| Secondary | Cardiac afterload index | g/cm^2 | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing systolic function: the stroke volume | ml | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing systolic function: cardiac output | l/min | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing systolic function: peripheral vascular resistance | Pa.s/m^3 | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing systolic function: fractional shortening | Baseline (Day 0; transversal study) | No | |
| Secondary | Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler | cm.s-1 | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing systolic function: global longitudinal strain | Baseline (Day 0; transversal study) | No | |
| Secondary | Ventricular-arterial coupling | relative units | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity | cm/s | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity | cm/s | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity | relative units | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler | cm/s | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler | cm/s | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler | relative units | Baseline (Day 0; transversal study) | No |
| Secondary | Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate | s^-1 | Baseline (Day 0; transversal study) | No |
| Secondary | Years of athletic training | Baseline (Day 0; transversal study) | No | |
| Secondary | Hours of athletic training per week | h/week | Baseline (Day 0; transversal study) | No |
| Secondary | Best performance in the last 6 months | Baseline (Day 0; transversal study) | No | |
| Secondary | Lower limb muscle mass | g | Baseline (Day 0; transversal study) | No |
| Secondary | Bone density | g/cm^2 | Baseline (Day 0; transversal study) | No |
| Secondary | Dietary protein intake | g/day | Baseline (Day 0; transversal study) | No |
| Secondary | Dietary protein intake | % calories per day | Baseline (Day 0; transversal study) | No |
| Secondary | Dietary calcium intake | mg/day | Baseline (Day 0; transversal study) | No |
| Secondary | Serum protein | g/l | Baseline (Day 0; transversal study) | No |
| Secondary | Serum calcium | mmol/l | Baseline (Day 0; transversal study) | No |
| Secondary | Serum phosphorus | mmol/l | Baseline (Day 0; transversal study) | No |
| Secondary | Serum parathyroid hormone | ng/l | Baseline (Day 0; transversal study) | No |
| Secondary | Serum vitamin D2 | µg/l | Baseline (Day 0; transversal study) | No |
| Secondary | Serum vitamin D3 | µg/l | Baseline (Day 0; transversal study) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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