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

NCT ID: NCT01577576

Last Updated: 2015-11-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-03-31

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).

Conditions

Monckeberg Medial Calcific Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonia Perez Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Université d'Avignon, Faculté des Sciences

Avignon, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2012-A00475-38

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/APM-01

Identifier Type: -

Identifier Source: org_study_id