Coronary Artery DiseasePhase 2NCT01754675
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
A Phase 2 study testing Soccer and Movie in people with Coronary Artery Disease, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.
Trial summary
Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Soccer and Movie
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- May 2012to Aug 2012
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery disease;
- Avai or Figueirense (brazilian soccer teams) fans
Who cannot join
- Acute coronary syndrome in less than 7 days
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina
About this study
Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators.
This study evaluates the hemodynamic response in Brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.
- Conditions
- Coronary Artery Disease
- Being tested
- Soccer, Movie
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoccerBehavioural
Watching the soccer match at the time that the favorite team is playing
MovieBehavioural
Watching a movie at the time that the favorite team is playing
| Study group | Role | What they receive |
|---|---|---|
| Soccer | Experimental | Watching the soccer match at the time that the favorite team is playing Receives: Behavioral: Soccer |
| Movie | Placebo comparator | Watching a movie at the time that the favorite team is playing Receives: Behavioral: Movie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average mean arterial pressure
To evaluate the difference between the average mean arterial pressure in patients with coronary artery disease, or not watching a game of soccer your favorite team;
Measured: 90 minutes
Secondary outcomes (5)
Mean heart rate
To evaluate the difference between the mean heart rate;
Measured: 90 minutes
Systolic blood pressure
To evaluate the difference between the systolic blood pressure;
Measured: 90 minutes
Diastolic blood pressure
To evaluate the difference between the diastolic blood pressure;
Measured: 90 minutes
Double product
To evaluate the difference between the double product (the product of heart rate and systolic blood pressure);
Measured: 90 minutes
Angina
To evaluate the difference between the presence of angina;
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
- Investigators
- Daniel M Moreira, MD. MSc., Study chair, Instituto de Cardiologia de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754675
- Sponsor's protocol ID
- CAAE: 03807212.5.0000.0113
- Status last verified
- Dec 2012
- First submitted
- 18 Dec 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01754675
- Acronym / sponsor ID
- CAAE: 03807212.5.0000.0113
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Instituto de Cardiologia de Santa CatarinaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Dec 2012 (estimated)
- 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.
Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators.
This study evaluates the hemodynamic response in Brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soccer | Experimental | Behavioral: SoccerWatching the soccer match at the time that the favorite team is playing |
| Movie | Placebo comparator | Behavioral: MovieWatching a movie at the time that the favorite team is playing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary artery disease;
- Avai or Figueirense (brazilian soccer teams) fans
Key exclusion criteria (1 listed)
- Acute coronary syndrome in less than 7 days
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 |
|---|---|---|
| SoccerWatching the soccer match at the time that the favorite team is playing | Behavioural | Soccer |
| MovieWatching a movie at the time that the favorite team is playing | Behavioural | Movie |
Primary outcome
Average mean arterial pressure
Time frame: 90 minutes
To evaluate the difference between the average mean arterial pressure in patients with coronary artery disease, or not watching a game of soccer your favorite team;
5 secondary outcomes
Mean heart rate
Time frame: 90 minutes
Systolic blood pressure
Time frame: 90 minutes
Diastolic blood pressure
Time frame: 90 minutes
Double product
Time frame: 90 minutes
Angina
Time frame: 90 minutes
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 24 Dec 2012.
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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.
Daniel M Moreira, MD. MSc. study chair
Instituto de Cardiologia de Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Soccer and Movie in people with Coronary Artery Disease, run by Instituto de Cardiologia de Santa Catarina at 1 site in Brazil.
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 2 inclusion and 1 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 24 Dec 2012. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Average mean arterial pressure (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2012.