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临床试验/NCT03723954
NCT03723954已完成不适用

Evaluation of Heart Rate Variations of Golf Fans During the 2018 Edition of the Ryder Cup : the Ryder Heart Study

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2018年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
1
主要终点
Record and measure by Spider Flash-t of the increase in the heart rate peak

研究概览

简要总结

Ryder Heart is an exploratory study of the heart rate variations of golf fans during the 2018 edition of the Ryder Cup. The main objective is to evaluate the impact of stress and strong emotions on heart rate variations and the occurrence of rhythmic anomalies in golf fans during this high-level golf competition. Such data are actually poorly described in medical and scientific literature.

详细描述

In 1996, a Dutch research team highlighted, for the first time, a strong statistical relationship between the outcome of a football match and cardiovascular mortality in men over 45 years of age. An excess mortality was reported among football fans on June 22nd 1996, day of the elimination of the Dutch by the French team during the penalty shoot-out of the European Champions League. A more recent study by Ute Wilbert-Lampen et al., confirmed the relationship between football matches of the 2006 World Cup and the occurrence of cardiovascular events such as rhythm disorders and coronary syndromes among football fans. Two factors favoring increased cardiovascular risk appear to emerge from these different studies: high-level football matches (most often played at home) and strong support and passion for one's sports team. However, the physiopathological mechanisms involved have not been fully understood yet. In addition, very little data exists on sports other than football. The investigators research hypothesis is that cardiovascular events induced by the passion of a sports fan could not be unique to only one sport. The Ryder Cup, one of the biggest sporting events in the world, is the ideal event to collect consolidation elements for the investigators hypothesis.

The main phase of the Ryder Heart study will take place during the Ryder Cup from the 28th till the 30th of September 2018.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Man or a Woman golf fan ;
  • At least 18 years old ;
  • Either a healthy study volunteer or a study volunteer suffering from a heart disease ;
  • With or without an implantable cardioverter-defibrillator ;
  • Presence at the Golf National during at least one day of the Ryder Cup (September 28th and/or September 29th and/or September 30th, 2018);
  • Presence and available for study inclusion :
  • In the Ile de France zone on the eve of competition (September 27th, 2018);
  • At Golf National at least two hours before matches' beginning at competition days ;
  • In possession of official tickets issued by the organizers ;
  • To accept to wear an ECG Holter for heart rate recording at inclusion (V0) and at least one competition day (from September 28th to September 30th, 2018).

排除标准

  • Pregnant or lactating woman;
  • Medical contraindication to ECG Holter ;
  • Equipped with an implantable pacemaker ;
  • Total dependence to stimulation of cardiac defibrillator;
  • Suffering from a decompensated heart disease ;
  • History of severe allergy to angioedema-type electrodes ;
  • Body temperature under 36 celsius degree or equal or higher than 39 celsius degree at inclusion;
  • Not opposed to the use of data collected via recording and electromagnetic measurements of heart rate (ECG) for research purposes.

结局指标

主要结局

Record and measure by Spider Flash-t of the increase in the heart rate peak

时间窗: 3 days

The measure of the increase in the heart rate peak (in beats per minute) of study subjects at the days and times of golf matches will be performed with Spider Flash-t. The algorithms built into SpiderFlash-t detect episodes palpitations, syncope, atrial fibrillation and atrial flutter in addition to all other arrhythmias such as bradycardia and tachycardia in patients symptomatic and asymptomatic. The integrated SpiderFlash-t software includes a dedicated and specific algorithm for detect atrial fibrillation. This atrial fibrillation algorithm is independent of the algorithm main arrhythmia detection, also incorporated into SpiderFlash-t. So comparing the data recorded at V0 (baseline) with the data recorded during the golf match, a minimum increase in the heart rate peak of at least 10% (at days and times of golf meetings) will be considered a significant variation.

次要结局

  • average hourly variations of parameters related with heart rate(3 days)
  • Fan's passion score for golf(15 minutes)
  • Record and measure fan physical activity by ActiGraph GT3Xp(3 days)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

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