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

NCT03723954 | Completed

• 1 other identifier: 18_RIPH3-03
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rate

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 days

Secondary Outcomes (3)

• 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

Interventions

ECG Holter SpiderFlash-t DEVICE

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-t™ 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 DEVICE

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Golf fans attending at least one Ryder Cup match

You may qualify if:

• 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);
• 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 ;

You may not qualify if:

• 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 ;
• Not opposed to the use of data collected via recording and electromagnetic measurements of heart rate (ECG) for research purposes.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• MicroPort Orthopedics Inc.: collaborator
• Boston Pharmaceuticals: collaborator
• Pfizer: collaborator

Study Sites (1)

Golf National

Saint-Quentin-en-Yvelines, 78280, France

Location

Related Publications (2)

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

  PMID: 18512276 RESULT

• 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.

  PMID: 18803066 RESULT

Study Officials

• Fabrice DEMONIERE, MD

  CHU deMartinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 30, 2018
• Study Start: September 27, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the main publication of the results, for not limited time.
• Access Criteria: The conditions for the transfer of all or part of the database of the research are decided by the principal investigator / sponsor of the research and are the subject of a written contract.

Locations

FR (1)