Back to resultsCardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Soccer
Movie
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Coronary artery disease;
- Avai or Figueirense (brazilian soccer teams) fans
Exclusion Criteria:
- Acute coronary syndrome in less than 7 days
Sites / Locations
- Instituto de Cardiologia de Santa Catarina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Soccer
Movie
Arm Description
Watching the soccer match at the time that the favorite team is playing
Watching a movie at the time that the favorite team is playing
Outcomes
Primary Outcome Measures
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;
Secondary Outcome Measures
Mean heart rate
To evaluate the difference between the mean heart rate;
Systolic blood pressure
To evaluate the difference between the systolic blood pressure;
Diastolic blood pressure
To evaluate the difference between the diastolic blood pressure;
Double product
To evaluate the difference between the double product (the product of heart rate and systolic blood pressure);
Angina
To evaluate the difference between the presence of angina;
Full Information
NCT ID
NCT01754675
First Posted
December 18, 2012
Last Updated
December 20, 2012
Sponsor
Instituto de Cardiologia de Santa Catarina
1. Study Identification
Unique Protocol Identification Number
NCT01754675
Brief Title
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Official Title
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia de Santa Catarina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soccer
Arm Type
Experimental
Arm Description
Watching the soccer match at the time that the favorite team is playing
Arm Title
Movie
Arm Type
Placebo Comparator
Arm Description
Watching a movie at the time that the favorite team is playing
Intervention Type
Behavioral
Intervention Name(s)
Soccer
Intervention Description
Watching the soccer match at the time that the favorite team is playing
Intervention Type
Behavioral
Intervention Name(s)
Movie
Intervention Description
Watching a movie at the time that the favorite team is playing
Primary Outcome Measure Information:
Title
Average mean arterial pressure
Description
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;
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Mean heart rate
Description
To evaluate the difference between the mean heart rate;
Time Frame
90 minutes
Title
Systolic blood pressure
Description
To evaluate the difference between the systolic blood pressure;
Time Frame
90 minutes
Title
Diastolic blood pressure
Description
To evaluate the difference between the diastolic blood pressure;
Time Frame
90 minutes
Title
Double product
Description
To evaluate the difference between the double product (the product of heart rate and systolic blood pressure);
Time Frame
90 minutes
Title
Angina
Description
To evaluate the difference between the presence of angina;
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Coronary artery disease;
Avai or Figueirense (brazilian soccer teams) fans
Exclusion Criteria:
Acute coronary syndrome in less than 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Moreira, MD. MSc.
Organizational Affiliation
Instituto de Cardiologia de Santa Catarina
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Cardiologia de Santa Catarina
City
São José
State/Province
Santa Catarina
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
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