Calcifications, VascularEMASENCT07419126
Ultrasound Assessment of Arterial Medial Calcification in Endurance Athletes: A Prevalence Study
An observational study of Calcifications, Vascular, run by University Hospital, Grenoble.
Trial summary
Medial arterial calcification (MAC) is an under-recognized vascular condition that remains poorly characterized from an epidemiological perspective. In the general population, its estimated prevalence is approximately 2.5%, mainly based on ankle-brachial index measurements. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Calcifications, Vascular
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy endurance athletes volunteering for the study, engaging in more than 5 hours of high-intensity endurance exercise per week for at least the past 10 years.
Who may be able to join
- Healthy volunteer attending a sports medicine consultation for the performance of an exercise stress test*.
- Male or female subject.
- Age between 18 and 70 years, inclusive.
- High-level endurance athlete, with regular practice of endurance sports (trail running, road running, cycling, swimming, cross-country skiing, biathlon), with a MET-min/week > 2000, corresponding to more than 5 hours of vigorous physical activity per week, for more than 10 years.
- Affiliated with a social security system.
- No objection to participation in the study. * Undergoing a lower limb arterial ultrasound examination as part of routine clinical care.
Who cannot join
- Participants with type 1 or type 2 diabetes mellitus.
- Participants with chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
- Resting arterial hypertension.
- Established cardiovascular disease (coronary artery disease, stroke, or peripheral arterial disease).
- Protected or vulnerable populations as defined by French Public Health Code articles L1121-5 to L1121-8, including:
- pregnant or breastfeeding women, women in labor, individuals deprived of liberty by judicial or administrative decision, individuals receiving psychiatric care under articles L.3212-1 and L.3213-1, individuals admitted to healthcare or social institutions for purposes other than research, minors, individuals under legal protection, or individuals unable to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Medial arterial calcification (MAC) is an under-recognized vascular condition that remains poorly characterized from an epidemiological perspective. In the general population, its estimated prevalence is approximately 2.5%, mainly based on ankle-brachial index measurements. In contrast, prevalence exceeds 10% in high-risk populations such as patients with diabetes, chronic kidney disease, or established cardiovascular disease, with wide variability depending on the diagnostic method used.
In these populations, MAC is associated with adverse clinical outcomes, including critical limb ischemia, major amputation, and increased cardiovascular mortality, sometimes exceeding the prognostic impact of atherosclerosis. However, data on MAC in healthy individuals are currently lacking, and its clinical significance in this population remains unknown.
Read more
Endurance athletes represent a unique population exposed to prolonged and intense hemodynamic stress. Previous studies have reported increased coronary artery calcification in athletes with very high levels of physical activity, and differences according to sporting discipline. Incidental findings of MAC have also been observed in endurance athletes, raising the question of a potential association with training volume and vascular adaptations to long-term exercise.
The objective of this study is to assess the prevalence of medial arterial calcification in endurance athletes using ultrasound imaging, and to explore its relationship with training characteristics and cardiovascular risk markers.
- Conditions
- Calcifications, Vascular
- Keywords
- medial arterial calcification, endurance athletes
- Medical subject headings
- Vascular Calcification
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 |
|---|---|---|
| Healthy endurance athletes | Healthy volunteer attending a sports medicine consultation for the performance of an exercise stress test*. Male or female subject. Age between 18 and 70 years, inclusive. High-level endurance athlete, with regular practice of endurance sports (trail running, road running, cycling, swimming, cross-country skiing, biathlon), with a MET-min/week > 2000, corresponding to more than 5 hours of vigorous physical activity per week, for more than 10 years. Affiliated with a social security system. No objection to participation in the study. * Undergoing a lower limb arterial ultrasound examination as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of medial arterial calcification detected by ultrasound in the lower limb arteries
Qualitative variable: number of subjects with medial arterial calcification. Measurement method: lower limb arterial duplex ultrasound (common and superficial femoral arteries, popliteal arteries, anterior tibial arteries, posterior tibial arteries), using a severity score ranging from 0 to 4 per side, i.e. 0 to 8 in total (0: completely normal vessel; 1: calcifications extending over < 1 cm; 2: calcifications over 1-2 cm; 3: calcifications over 2-3 cm; 4: calcifications over > 3 cm). A score of 0 indicates absence of medial arterial calcification, whereas a score of ≥ 1 indicates presence of medial arterial calcification.
Measured: At enrollment (single assessment on the day of inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcifications, VascularStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Doutreleau, Doctor, Principal investigator, University Hospital, GrenobleChristophe Seinturier, Doctor, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419126
- Sponsor's protocol ID
- 38RC25.0430 - EMASE
- Acronym
- EMASE
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Arterial Medial Calcification in Endurance Athletes: A Prevalence Study
- ClinicalTrials.gov ID
- NCT07419126
- Acronym / sponsor ID
- EMASE / 38RC25.0430 - EMASE
- Conditions
- Calcifications, Vascular
- Keywords
- medial arterial calcification, endurance athletes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- 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.
Medial arterial calcification (MAC) is an under-recognized vascular condition that remains poorly characterized from an epidemiological perspective. In the general population, its estimated prevalence is approximately 2.5%, mainly based on ankle-brachial index measurements. In contrast, prevalence exceeds 10% in high-risk populations such as patients with diabetes, chronic kidney disease, or established cardiovascular disease, with wide variability depending on the diagnostic method used.
In these populations, MAC is associated with adverse clinical outcomes, including critical limb ischemia, major amputation, and increased cardiovascular mortality, sometimes exceeding the prognostic impact of atherosclerosis. However, data on MAC in healthy individuals are currently lacking, and its clinical significance in this population remains unknown.
Endurance athletes represent a unique population exposed to prolonged and intense hemodynamic stress. Previous studies have reported increased coronary artery calcification in athletes with very high levels of physical activity, and differences according to sporting discipline. Incidental findings of MAC have also been observed in endurance athletes, raising the question of a potential association with training volume and vascular adaptations to long-term exercise.
The objective of this study is to assess the prevalence of medial arterial calcification in endurance athletes using ultrasound imaging, and to explore its relationship with training characteristics and cardiovascular risk markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy endurance athletes | – | –Healthy volunteer attending a sports medicine consultation for the performance of an exercise stress test*. Male or female subject. Age between 18 and 70 years, inclusive. High-level endurance athlete, with regular practice of endurance sports (trail running, road running, cycling, swimming, cross-country skiing, biathlon), with a MET-min/week > 2000, corresponding to more than 5 hours of vigorous physical activity per week, for more than 10 years. Affiliated with a social security system. No objection to participation in the study. * Undergoing a lower limb arterial ultrasound examination as part of routine clinical care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy endurance athletes volunteering for the study, engaging in more than 5 hours of high-intensity endurance exercise per week for at least the past 10 years.
Key inclusion criteria (6 listed)
- Healthy volunteer attending a sports medicine consultation for the performance of an exercise stress test*.
- Male or female subject.
- Age between 18 and 70 years, inclusive.
- High-level endurance athlete, with regular practice of endurance sports (trail running, road running, cycling, swimming, cross-country skiing, biathlon), with a MET-min/week > 2000, corresponding to more than 5 hours of vigorous physical activity per week, for more than 10 years.
- Affiliated with a social security system.
Key exclusion criteria (6 listed)
- Participants with type 1 or type 2 diabetes mellitus.
- Participants with chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m².
- Resting arterial hypertension.
- Established cardiovascular disease (coronary artery disease, stroke, or peripheral arterial disease).
- Protected or vulnerable populations as defined by French Public Health Code articles L1121-5 to L1121-8, including:
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 or absence of medial arterial calcification detected by ultrasound in the lower limb arteries
Time frame: At enrollment (single assessment on the day of inclusion)
Qualitative variable: number of subjects with medial arterial calcification. Measurement method: lower limb arterial duplex ultrasound (common and superficial femoral arteries, popliteal arteries, anterior tibial arteries, posterior tibial arteries), using a severity score ranging from 0 to 4 per side, i.e. 0 to 8 in total (0: completely normal vessel; 1: calcifications extending over < 1 cm; 2: calcifications over 1-2 cm; 3: calcifications over 2-3 cm; 4: calcifications over > 3 cm). A score of 0 indicates absence of medial arterial calcification, whereas a score of ≥ 1 indicates presence of medial arterial calcification.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Stéphane Doutreleau, Doctor principal investigator
University Hospital, Grenoble
Christophe Seinturier, Doctor study director
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Calcifications, Vascular, run by University Hospital, Grenoble.
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 6 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Melkemi, Resident (+33606471880 ext. +33, melkmarwa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of medial arterial calcification detected by ultrasound in the lower limb arteries (time frame: At enrollment (single assessment on the day of inclusion)). 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 18 Feb 2026.