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Not yet recruiting NCT07419126

Ultrasound Assessment of Arterial Medial Calcification in Endurance Athletes: A Prevalence Study

Observational Calcifications, Vascular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Calcifications, Vascular. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07419126 · 38RC25.0430 - EMASE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗