NCT03025737Unknown不适用
Semmelweis Sport - Complex Cardiovascular Screening of Elite, Recreational, Young and Master Athletes
Semmelweis University Heart and Vascular Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The primary analysis will be an investigation regarding the athletic adaptation using CMR
研究概览
简要总结
The aim of the present proposal is to investigate the development of distinct morphological, functional, biochemical and molecular aspects of short- and long-term sport-induced changes in the heart, to get a better understanding on the (patho)physiology of athlete's heart. The main goal of our research is to deepen our knowledge on the proper differentiation between beneficial (physiological) and harmful (pathological) consequences of professional sport, thereby effectively preventing potential cardiovascular complications of athletes.
详细描述
CLINICAL METHODS
- Sport specific questionnaire, patient history and physical examinations - In our detailed questionnaire, specific information is collected about quantity and quality of training, personal and family history and presence of sport specific and general symptoms.
- Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters associated with physical exercise are planned to be measured, such as cardiac biomarkers.
- 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
- Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
- Detailed echocardiography
- Detailed CMR examination
- Body composition analysis - With a sophisticated bio-electrical impedance analysis, comprehensive whole body composition and hydration analysis will be performed.
- Cardiopulmonary exercise testing - Sport specific protocols will be used on both treadmill and bike ergometers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no known cardiovascular disease
- •history of sport activity (athletes)
- •no history of competitive sport (controls)
排除标准
- •History of known relevant cardiac disease (including cardiomyopathies)
- •Contraindication to MRI or cardiopulmonary exercise testing
结局指标
主要结局
The primary analysis will be an investigation regarding the athletic adaptation using CMR
时间窗: Baseline
次要结局
- The primary analysis will be an investigation regarding the athletic adaptation using cardiopulmonary exercise testing(Baseline)
- The primary analysis will be an investigation regarding the athletic adaptation using 24-Hour Holter ECG(Baseline)
- The primary analysis will be an investigation regarding the athletic adaptation using resting ECG(Baseline)
研究者
Bela Merkely
Principal Investigator
Semmelweis University Heart and Vascular Center
研究点 (1)
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