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临床试验/NCT07419126
NCT07419126尚未招募不适用

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

University Hospital, Grenoble0 个研究点目标入组 60 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
Presence or absence of medial arterial calcification detected by ultrasound in the lower limb arteries

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Presence or absence of medial arterial calcification detected by ultrasound in the lower limb arteries

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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