Clinical trial NCT03723954: Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup
Official title: Evaluation of Heart Rate Variations of Golf Fans During the 2018 Edition of the Ryder Cup : the Ryder Heart Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: MicroPort Orthopedics Inc.
name: Boston Pharmaceuticals
name: Pfizer
First posted: 2018-10-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Golf fans attending at least one Ryder Cup match

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Record and measure by Spider Flash-t of the increase in the heart rate peak
timeFrame: 3 days
Secondary outcomes:
measure: average hourly variations of parameters related with heart rate
timeFrame: 3 days
measure: Fan's passion score for golf
timeFrame: 15 minutes
measure: Record and measure fan physical activity by ActiGraph GT3Xp
timeFrame: 3 days
Other outcomes:
Locations:
city: Saint-Quentin-en-Yvelines
country: France
facility: Golf National
Study officials:
affiliation: CHU deMartinique
name: Fabrice DEMONIERE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409. No abstract available.
citation: Vallerand RJ, Ntoumanis N, Philippe FL, Lavigne GL, Carbonneau N, Bonneville A, Lagace-Labonte C, Maliha G. On passion and sports fans: a look at football. J Sports Sci. 2008 Oct;26(12):1279-93. doi: 10.1080/02640410802123185.