NCT07419126

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Feb 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Feb 2026Oct 2026

Study Start

First participant enrolled

February 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

medial arterial calcificationendurance athletes

Outcome Measures

Primary Outcomes (1)

  • 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.

    At enrollment (single assessment on the day of inclusion)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stéphane Doutreleau, Doctor

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR
  • Christophe Seinturier, Doctor

    University Hospital, Grenoble

    STUDY DIRECTOR

Central Study Contacts

Marwa Melkemi, Resident

CONTACT

Christophe Seinturier, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share