Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup

NCT ID: NCT03723954

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-27

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Heart Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ECG Holter SpiderFlash-t

Record at visit V0 (day without match) and the competition days (Visit V1, V2 et V3) during the matches the heart rate of the golf fans.

SpiderFlash-tâ„¢ from MicroPort is a long-lasting event recorder set in walking position by the investigator the day of the record and it is activated by detecting rhythm anomalies. This recorder is a Class IIA medical device (according to European Economic Community Directive 93/42). It benefits from European Economic marking.

Intervention Type DEVICE

Actigraph GT3Xp

Record the study participant's physical activity while we record his heart rate.

The GT3Xp based activity monitors provide objective measurements of human activity and are used in many research and clinical applications. It includes a micro-electro-mechanical system (MEMS) based accelerometer and an ambient light sensor. It benefits from CE marking and FDA agreement (Class II medical device).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role collaborator

Boston Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice DEMONIERE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU deMartinique

Locations

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Golf National

Saint-Quentin-en-Yvelines, , France

Site Status

Countries

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France

References

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Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409. No abstract available.

Reference Type RESULT
PMID: 18512276 (View on PubMed)

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.

Reference Type RESULT
PMID: 18803066 (View on PubMed)

Other Identifiers

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18_RIPH3-03

Identifier Type: -

Identifier Source: org_study_id

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