Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes (MediaSport)

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.

Study Overview

• Status: Terminated
• Conditions: Monckeberg Medial Calcific Sclerosis

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).

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Université d'Avignon, Faculté des Sciences
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Upper-body athletes; This group includes swimmers, rowers or kayakers with a history of at least 10 years of intense training, and performance in regional competitions for the past five years.
Lower-body athletes; This group includes runners (marathon or trail) and cyclists with a history of at least 10 years of intense training, and performance in regional competitions for the past five years.
Sedentary volunteers; This group of healthy volunteers does not participate in athletic activity for more than two hours per week. They are matched by age and sex with the athletic groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence / absence of intra parietal calcification of lower limb arteries	Baseline (Day 0; transversal study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of intra parietal calcification of lower limb arteries	Score ranging from 0 to 3	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)
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)
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	mm^2/mmHg	Baseline (Day 0; transversal study)
Compliance of the carotid artery	mm^2/mmHg	Baseline (Day 0; transversal study)
Distensibility of the carotid artery	mmHg^-1*10^-2	Baseline (Day 0; transversal study)
Arterial wave velocity in lower limb	m/s	Baseline (Day 0; transversal study)
Arterial wave velocity in upper limb	m/s	Baseline (Day 0; transversal study)
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	relative units	Baseline (Day 0; transversal study)
Systolic pressure index for the big toe	relative units	Baseline (Day 0; transversal study)
Cardiac afterload index	g/cm^2	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: the stroke volume	ml	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: cardiac output	l/min	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: peripheral vascular resistance	Pa.s/m^3	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: fractional shortening		Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler	cm.s-1	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: global longitudinal strain		Baseline (Day 0; transversal study)
Ventricular-arterial coupling	relative units	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity	cm/s	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity	cm/s	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity	relative units	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler	cm/s	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler	cm/s	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler	relative units	Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate	s^-1	Baseline (Day 0; transversal study)
Years of athletic training		Baseline (Day 0; transversal study)
Hours of athletic training per week	h/week	Baseline (Day 0; transversal study)
Best performance in the last 6 months		Baseline (Day 0; transversal study)
Lower limb muscle mass	g	Baseline (Day 0; transversal study)
Bone density	g/cm^2	Baseline (Day 0; transversal study)
Dietary protein intake	g/day	Baseline (Day 0; transversal study)
Dietary protein intake	% calories per day	Baseline (Day 0; transversal study)
Dietary calcium intake	mg/day	Baseline (Day 0; transversal study)
Serum protein	g/l	Baseline (Day 0; transversal study)
Serum calcium	mmol/l	Baseline (Day 0; transversal study)
Serum phosphorus	mmol/l	Baseline (Day 0; transversal study)
Serum parathyroid hormone	ng/l	Baseline (Day 0; transversal study)
Serum vitamin D2	µg/l	Baseline (Day 0; transversal study)
Serum vitamin D3	µg/l	Baseline (Day 0; transversal study)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: April 12, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (ESTIMATE): April 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 27, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Athletes; Sedentary volunteers
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Vascular Calcification; Monckeberg Medial Calcific Sclerosis
• Other Study ID Numbers: LOCAL/2012/APM-01; 2012-A00475-38 (OTHER: RCB number)