Monckeberg Medial Calcific SclerosisMediaSportNCT01577576
Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes
An observational study of Monckeberg Medial Calcific Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Monckeberg Medial Calcific Sclerosis
- How many people
- 56 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Université d'Avignon, Faculté des Sciences
Avignon, 84000
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the detailed description
Secondary objectives of this study are:
- 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.
- 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.
- Examine the relationship between the properties of the arterial wall and peripheral perfusion pressures.
- Examine the relationship between the properties of the arterial wall, changes in afterload, morphology and systolic heart function.
- Analyze the relationships between the parameters characterizing the arterial wall and muscle mass of the lower limbs.
- Analyze the relationship between the presence of intramural calcification and bone density determined by densitometry.
- Analyze the relationship between the presence of intramural calcification and dietary protein intake and calcium.
- Compare indices of pressure at the ankle and toe, depending on the extent of calcification.
- Create a collection of biological samples (serum).
- Conditions
- Monckeberg Medial Calcific Sclerosis
- Keywords
- Athletes, Sedentary volunteers
- Medical subject headings
- Monckeberg Medial Calcific Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence / absence of intra parietal calcification of lower limb arteries
Measured: Baseline (Day 0; transversal study)
Secondary outcomes (48)
Extent of intra parietal calcification of lower limb arteries
Score ranging from 0 to 3
Measured: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the common femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the common femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the superficial femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the superficial femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the common carotid artery (mm)
Measured: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the common carotid artery (mm)
Measured: Baseline (Day 0; transversal study)
Thickness of the intima-media of the common femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Thickness of the intima-media of the superficial femoral artery (mm)
Measured: Baseline (Day 0; transversal study)
Thickness of the intima-media of the common carotid artery (mm)
Measured: Baseline (Day 0; transversal study)
Local parietal compliance of the superficial femoral artery
mm^2/mmHg
Measured: Baseline (Day 0; transversal study)
Compliance of the carotid artery
mm^2/mmHg
Measured: Baseline (Day 0; transversal study)
Distensibility of the carotid artery
mmHg^-1*10^-2
Measured: Baseline (Day 0; transversal study)
Arterial wave velocity in lower limb
m/s
Measured: Baseline (Day 0; transversal study)
Arterial wave velocity in upper limb
m/s
Measured: Baseline (Day 0; transversal study)
Endothelium-dependent vasorelaxation in the femoral artery
Measured: Baseline (Day 0; transversal study)
Postischemic vasomotor response at the (skin) microcirculatory level
Measured: Baseline (Day 0; transversal study)
Systolic pressure index at the ankle
relative units
Measured: Baseline (Day 0; transversal study)
Systolic pressure index for the big toe
relative units
Measured: Baseline (Day 0; transversal study)
Cardiac afterload index
g/cm^2
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: the stroke volume
ml
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: cardiac output
l/min
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: peripheral vascular resistance
Pa.s/m^3
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: fractional shortening
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler
cm.s-1
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: global longitudinal strain
Measured: Baseline (Day 0; transversal study)
Ventricular-arterial coupling
relative units
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity
cm/s
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity
cm/s
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity
relative units
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler
cm/s
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler
cm/s
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler
relative units
Measured: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate
s^-1
Measured: Baseline (Day 0; transversal study)
Years of athletic training
Measured: Baseline (Day 0; transversal study)
Hours of athletic training per week
h/week
Measured: Baseline (Day 0; transversal study)
Best performance in the last 6 months
Measured: Baseline (Day 0; transversal study)
Lower limb muscle mass
g
Measured: Baseline (Day 0; transversal study)
Bone density
g/cm^2
Measured: Baseline (Day 0; transversal study)
Dietary protein intake
g/day
Measured: Baseline (Day 0; transversal study)
Dietary protein intake
% calories per day
Measured: Baseline (Day 0; transversal study)
Dietary calcium intake
mg/day
Measured: Baseline (Day 0; transversal study)
Serum protein
g/l
Measured: Baseline (Day 0; transversal study)
Serum calcium
mmol/l
Measured: Baseline (Day 0; transversal study)
Serum phosphorus
mmol/l
Measured: Baseline (Day 0; transversal study)
Serum parathyroid hormone
ng/l
Measured: Baseline (Day 0; transversal study)
Serum vitamin D2
µg/l
Measured: Baseline (Day 0; transversal study)
Serum vitamin D3
µg/l
Measured: Baseline (Day 0; transversal study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Inclusion curve too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monckeberg Medial Calcific SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Perez Martin, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577576
- Sponsor's protocol ID
- LOCAL/2012/APM-01
- Other IDs
- 2012-A00475-38
- Acronym
- MediaSport
- Status last verified
- Nov 2015
- First submitted
- 12 Apr 2012
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01577576
- Acronym / sponsor ID
- MediaSport / LOCAL/2012/APM-01
- Conditions
- Monckeberg Medial Calcific Sclerosis
- Keywords
- Athletes, Sedentary volunteers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion curve too slow.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Examine the relationship between the properties of the arterial wall and peripheral perfusion pressures.
- Examine the relationship between the properties of the arterial wall, changes in afterload, morphology and systolic heart function.
- Analyze the relationships between the parameters characterizing the arterial wall and muscle mass of the lower limbs.
- Analyze the relationship between the presence of intramural calcification and bone density determined by densitometry.
- Analyze the relationship between the presence of intramural calcification and dietary protein intake and calcium.
- Compare indices of pressure at the ankle and toe, depending on the extent of calcification.
- Create a collection of biological samples (serum).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence / absence of intra parietal calcification of lower limb arteries
Time frame: Baseline (Day 0; transversal study)
48 secondary outcomes
Extent of intra parietal calcification of lower limb arteries
Time frame: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the common femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the common femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the superficial femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the superficial femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Inner diameter of the intima-media of the common carotid artery (mm)
Time frame: Baseline (Day 0; transversal study)
Outer diameter of the intima-media of the common carotid artery (mm)
Time frame: Baseline (Day 0; transversal study)
Thickness of the intima-media of the common femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Thickness of the intima-media of the superficial femoral artery (mm)
Time frame: Baseline (Day 0; transversal study)
Thickness of the intima-media of the common carotid artery (mm)
Time frame: Baseline (Day 0; transversal study)
Local parietal compliance of the superficial femoral artery
Time frame: Baseline (Day 0; transversal study)
Compliance of the carotid artery
Time frame: Baseline (Day 0; transversal study)
Distensibility of the carotid artery
Time frame: Baseline (Day 0; transversal study)
Arterial wave velocity in lower limb
Time frame: Baseline (Day 0; transversal study)
Arterial wave velocity in upper limb
Time frame: Baseline (Day 0; transversal study)
Endothelium-dependent vasorelaxation in the femoral artery
Time frame: Baseline (Day 0; transversal study)
Postischemic vasomotor response at the (skin) microcirculatory level
Time frame: Baseline (Day 0; transversal study)
Systolic pressure index at the ankle
Time frame: Baseline (Day 0; transversal study)
Systolic pressure index for the big toe
Time frame: Baseline (Day 0; transversal study)
Cardiac afterload index
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: the stroke volume
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: cardiac output
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: peripheral vascular resistance
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: fractional shortening
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: speed of the S-wave according to tissue Doppler
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing systolic function: global longitudinal strain
Time frame: Baseline (Day 0; transversal study)
Ventricular-arterial coupling
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral A wave velocity
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / transmitral A wave velocity
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Em wave velocity according to tissue Doppler
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: maximum Am wave velocity according to tissue Doppler
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: transmitral E wave velocity / maximum Em wave velocity according to tissue Doppler
Time frame: Baseline (Day 0; transversal study)
Echocardiographic parameters analyzing diastolic function: early diastolic strain-rate
Time frame: Baseline (Day 0; transversal study)
Years of athletic training
Time frame: Baseline (Day 0; transversal study)
Hours of athletic training per week
Time frame: Baseline (Day 0; transversal study)
Best performance in the last 6 months
Time frame: Baseline (Day 0; transversal study)
Lower limb muscle mass
Time frame: Baseline (Day 0; transversal study)
Bone density
Time frame: Baseline (Day 0; transversal study)
Dietary protein intake
Time frame: Baseline (Day 0; transversal study)
Results and safety
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Perez Martin, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monckeberg Medial Calcific Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence / absence of intra parietal calcification of lower limb arteries (time frame: Baseline (Day 0; transversal study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.