Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes (MediaSport)
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| First Received Date ICMJE | April 12, 2012 | ||||||||
| Last Updated Date | March 26, 2013 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Presence / absence of intra parietal calcification of lower limb arteries [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01577576 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 "upper-limb" and "lower-limb" endurance athletes without cardiovascular risk as compared to (each other and to) sedentary controls. |
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| 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). |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: A non-fasting venous blood sample is required for the following cofactors:
Left-over serum will be stored in the Nîmes University Hospital "Sérotheque" (serum collection). |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The study population is composed of three groups of healthy volunteers: (1) upper body athletes; (2) lower-body athletes and (3) sedentary volunteers. All volunteers are between the ages of 25 and 40. Upper-body and lower-body athletes are matched according to years of intense athletic training and hours of weekly training. Sedentary volunteers are matched with athletes according to age and sex. |
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| Condition ICMJE | Monckeberg Medial Calcific Sclerosis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria for athletic and sedentary volunteers:
Inclusion Criteria for athletic volunteers only:
Exclusion Criteria for athletic and sedentary volunteers:
Exclusion Criteria for sedentary volunteers only:
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| Gender | Both | ||||||||
| Ages | 25 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01577576 | ||||||||
| Other Study ID Numbers ICMJE | LOCAL/2012/APM-01, 2012-A00475-38 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nīmes | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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