Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup
NCT ID: NCT03723954
Last Updated: 2018-10-30
Study Results
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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COMPLETED
47 participants
OBSERVATIONAL
2018-09-27
2018-09-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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MicroPort Orthopedics Inc.
INDUSTRY
Boston Pharmaceuticals
INDUSTRY
Pfizer
INDUSTRY
University Hospital Center of Martinique
OTHER
Responsible Party
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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
Countries
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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.
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.
Other Identifiers
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18_RIPH3-03
Identifier Type: -
Identifier Source: org_study_id
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