Heart RateRyderHeartNCT03723954

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

An observational study of Heart Rate, run by University Hospital Center of Martinique at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Heart Rate
What is being tested?: ECG Holter SpiderFlash-t and Actigraph GT3Xp
Type of treatment: Medical device
How many people: 47 participants
Where: 1 siteFrance
Study dates: 27 Sep 2018to 30 Sep 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Golf fans attending at least one Ryder Cup match

Who may be able to join

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 :

Show all 10Show fewer

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Golf National
Saint-Quentin-en-Yvelines, 78280

Other trials in France

About this study

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

Read the 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.

Conditions: Heart Rate
Being tested: ECG Holter SpiderFlash-t, Actigraph GT3Xp

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ECG Holter SpiderFlash-tDevice
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 GT3XpDevice
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 days

Secondary outcomes (3)

average hourly variations of parameters related with heart rate
The exploratory nature of the Ryder Heart study does not allow adequate consideration of potential confounding factors that may affect heart rate. Thus, the variations of this heart rate can be described according to several characteristics: the intensity of the physical activity of the fans during the Ryder Cup using an Actigraph GT3Xp and the passion supporter for golf The data recorded by SpiderFlash-t will be analyzed by the analysis program of MicroPort. This program produces an automatic report of a classical and spectral analysis of the variability of the heart rate. The heart rate, its variability as well as the rhythmic events will thus be studied, with the description of the amplitudes, temporal, frequency and rhythmic parameters.
Measured: 3 days
Fan's passion score for golf
The golf fan's degree of passion will be evaluated by a questionnaire including a series of items, inspired by studies by Vallerand et al. and Wann and Branscombe which help to classify the fans in three categories : little, moderately and very passionate.The scale includes 16 questions with answers choice going from 0 to 3. To whom will obtain a total score 0-16 = little passionate. To whom will obtain a total score 17-32 = moderately passionate. To whom will obtain a total score 33-48 = very passionate.
Measured: 15 minutes
Record and measure fan physical activity by ActiGraph GT3Xp
The physical activity level of study participants will be quantified directly every day of competition, using a physical activity monitor / accelerometer type ActiGraph GT3Xp. This device will collect various information such as mouvements, gross acceleration, caloric flow, energy expenditure, active energy expenditure, the duration of physical activity and the number of steps of the supporter. The number of steps of the supporter is used to take into account a confounding factor (effect of the physical activity of the supporter on his heart rate) and estimate the main judgment criterion reliably.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201830 Sep 2018

First posted30 Oct 2018
Study start27 Sep 2018
Primary completion30 Sep 2018
Study completion30 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart RateStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03723954
Sponsor's protocol ID: 18_RIPH3-03
Acronym: RyderHeart
Status last verified: Oct 2018
First submitted: 22 Oct 2018
Last updated: 30 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All collected IPD, all IPD that underlie results in a publication.

Publications

Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409. No abstract available.
PubMed 18512276
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.
PubMed 18803066

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Heart Rate trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Heart Rate Variations of Golf Fans During the 2018 Edition of the Ryder Cup : the Ryder Heart Study
ClinicalTrials.gov ID: NCT03723954
Acronym / sponsor ID: RyderHeart / 18_RIPH3-03
Conditions: Heart Rate
Study type: Observational
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: University Hospital Center of MartiniqueUniversity, hospital or other
Collaborators: MicroPort Orthopedics Inc., Boston Pharmaceuticals, Pfizer
Study start: 27 Sep 2018 (actual)
Primary completion: 30 Sep 2018 (actual)
Study completion: 30 Sep 2018 (actual)
First posted: 30 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Golf fans attending at least one Ryder Cup match

Key inclusion criteria (10 listed)

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);

Key exclusion criteria (8 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ECG Holter SpiderFlash-tRecord 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.	Device	–
Actigraph GT3XpRecord 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).	Device	–

Primary outcome

Record and measure by Spider Flash-t of the increase in the heart rate peak
Time frame: 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.

3 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
Results publication: PubMed 18512276Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409. No abstract available.
Results publication: PubMed 18803066Vallerand 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.
Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fabrice DEMONIERE, MD principal investigator

CHU deMartinique

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Rate, run by University Hospital Center of Martinique at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Record and measure by Spider Flash-t of the increase in the heart rate peak (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723954, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.