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临床试验/NCT07625488
NCT07625488Enrolling By Invitation不适用

Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
250
试验地点
2

研究概览

简要总结

Regular endurance exercise is widely known to improve cardiovascular health and reduce the risk of heart disease. Yet several imaging studies have shown that male endurance athletes have a higher prevalence of coronary artery calcification (CAC) and calcified plaque than less active individuals. It remains unclear whether this represents harmful progression of coronary artery disease or a more benign, stable form of atherosclerosis. Understanding this distinction is essential, because coronary atherosclerosis is the leading cause of exercise-related cardiac events in athletes >35 years.

The MARC-3 study is the second long-term follow-up of the original Measuring Athlete's Risk of Cardiovascular Events (MARC) cohort and aims to clarify how lifelong exercise training influences coronary artery health.

The study will:

  1. examine how long-term exercise patterns relate to the progression of coronary atherosclerosis;
  2. assess plaque characteristics using artificial-intelligence based quantitative coronary CT angiography (AI-QCT);
  3. identify biological markers that may link exercise to plaque development; and
  4. evaluate long-term clinical outcomes, including all-cause mortality and major adverse cardiovascular events (MACE).

Our working hypothesis is that endurance exercise predominantly leads to more stable, calcified plaque, and that mechanisms such as exercise-induced hypertension, inflammation, lipid regulation, and genetic background may provide an explanation for the unexpected results observed in previous studies.

详细描述

For a detailed description, please see the attached study protocol under 'Documents'.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • - Previous participation in the original MARC study (enrolled between 2012-2014).

排除标准

  • Inability to provide written informed consent.
  • Not willing to receive information about potential incidental CT findings.
  • Concurrent participation in an interventional study targeting cardiovascular health.
  • Additional exclusion criteria for CCTA:
  • Not willing to undergo CCTA with intravenous contrast.
  • History of severe allergic reaction to iodinated contrast agents.
  • Renal dysfunction (eGFR < 30 mL/min/1.73 m²).
  • Additional exclusion criteria for maximal exercise testing:
  • Absolute contraindications to maximal exercise testing as defined by institutional SOPs, including but not limited to:
  • Recent acute myocardial infarction (3-5 days)
  • Unstable angina
  • Uncontrolled arrhythmias with symptoms or hemodynamic compromise
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Uncontrolled heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Lower extremity thrombosis
  • Suspected aortic dissection
  • Uncontrolled asthma
  • Pulmonary edema
  • Resting room-air oxygen saturation ≤ 85 percent
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that impair or are aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)
  • Mental impairment preventing cooperation

研究组 & 干预措施

MARC-3 cohort

Participants in this cohort are the surviving and traceable members of the original MARC study, which enrolled 318 middle-aged male amateur endurance athletes between 2012 and 2014. In the first follow-up (MARC-2), 291 participants were successfully re-examined. All participants have a lifelong history of regular endurance exercise. In MARC-3, they undergo repeat evaluation of coronary atherosclerosis, cardiopulmonary fitness, exercise exposure, biomarkers, and genetic factors approximately 12.5 years after baseline.

结局指标

主要结局

未指定

次要结局

  • Peripheral Atherosclerosis and Vascular Function(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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