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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01577576
First received: April 12, 2012
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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.


Condition
Monckeberg Medial Calcific Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence / absence of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extent of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Outer diameter of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Inner diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Outer diameter of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Inner diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Outer diameter of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Thickness of the intima-media of the common femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Thickness of the intima-media of the superficial femoral artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Thickness of the intima-media of the common carotid artery (mm) [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Local parietal compliance of the superficial femoral artery [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mm^2/mmHg

  • Compliance of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mm^2/mmHg

  • Distensibility of the carotid artery [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mmHg^-1*10^-2

  • Arterial wave velocity in lower limb [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    m/s

  • Arterial wave velocity in upper limb [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    m/s

  • Endothelium-dependent vasorelaxation in the femoral artery [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Postischemic vasomotor response at the (skin) microcirculatory level [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Systolic pressure index at the ankle [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    relative units

  • Systolic pressure index for the big toe [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    relative units

  • Cardiac afterload index [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    g/cm^2

  • Echocardiographic parameters analyzing systolic function: the stroke volume [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    ml

  • Echocardiographic parameters analyzing systolic function: cardiac output [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    l/min

  • Echocardiographic parameters analyzing systolic function: peripheral vascular resistance [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    Pa.s/m^3

  • Echocardiographic parameters analyzing systolic function: fractional shortening [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    cm.s-1

  • Echocardiographic parameters analyzing systolic function: global longitudinal strain [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Ventricular-arterial coupling [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    relative units

  • Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    cm/s

  • Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    cm/s

  • Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    relative units

  • Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    cm/s

  • Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    cm/s

  • Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    relative units

  • Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    s^-1

  • Years of athletic training [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Hours of athletic training per week [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    h/week

  • Best performance in the last 6 months [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
  • Lower limb muscle mass [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    g

  • Bone density [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    g/cm^2

  • Dietary protein intake [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    g/day

  • Dietary protein intake [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    % calories per day

  • Dietary calcium intake [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mg/day

  • Serum protein [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    g/l

  • Serum calcium [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mmol/l

  • Serum phosphorus [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    mmol/l

  • Serum parathyroid hormone [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    ng/l

  • Serum vitamin D2 [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    µg/l

  • Serum vitamin D3 [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]
    µg/l


Biospecimen Retention:   Samples Without DNA

A non-fasting venous blood sample is required for the following cofactors:

  • serum protein
  • serum calcium
  • phosphorus
  • PTH
  • Vitamin D2 and D3

Left-over serum will be stored in the Nîmes University Hospital "Sérotheque" (serum collection).


Estimated Enrollment: 90
Study Start Date: September 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577576

Contacts
Contact: Antonia Perez Martin, MD +33.(0)4.66.68.33.13 antonia.perez.martin@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Université d'Avignon, Faculté des Sciences Recruiting
Avignon, France, 84000
Sub-Investigator: Agnès Vinet-Julian, PhD         
Sub-Investigator: Guillaume Walther, PhD         
Sub-Investigator: Claire Fuentes         
Sub-Investigator: Lucie Goret         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Antonia Perez Martin, MD         
Sub-Investigator: Isabelle Aïchoun, MD         
Sub-Investigator: Monika Di Rienzo, MD         
Sub-Investigator: Iris Schuster, MD         
Sub-Investigator: Michel Dauzat, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Antonia Perez Martin, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01577576     History of Changes
Other Study ID Numbers: LOCAL/2012/APM-01, 2012-A00475-38
Study First Received: April 12, 2012
Last Updated: November 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Athletes
Sedentary volunteers

Additional relevant MeSH terms:
Calcinosis
Monckeberg Medial Calcific Sclerosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014