- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419126
Ultrasound Assessment of Arterial Medial Calcification in Endurance Athletes: A Prevalence Study (EMASE)
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marwa Melkemi, Resident
- Phone Number: +33 +33606471880
- Email: melkmarwa@gmail.com
Study Contact Backup
- Name: Christophe Seinturier, Doctor
- Phone Number: +33 +33645270690
- Email: CSeinturier@chu-grenoble.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At enrollment (single assessment on the day of inclusion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stéphane Doutreleau, Doctor, University Hospital, Grenoble
- Study Director: Christophe Seinturier, Doctor, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC25.0430 - EMASE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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