Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease

• ClinicalTrials.gov Identifier: NCT01754675
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: December 24, 2012
• Sponsor: Instituto de Cardiologia de Santa Catarina
• Information provided by (Responsible Party): Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina

Tracking Information

• First Submitted Date: December 18, 2012
• First Posted Date: December 21, 2012
• Last Update Posted Date: December 24, 2012
• Study Start Date: May 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2012)

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;

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 20, 2012)

• Mean heart rate [ Time Frame: 90 minutes ]
  To evaluate the difference between the mean heart rate;
• Systolic blood pressure [ Time Frame: 90 minutes ]
  To evaluate the difference between the systolic blood pressure;
• Diastolic blood pressure [ Time Frame: 90 minutes ]
  To evaluate the difference between the diastolic blood pressure;
• Double product [ Time Frame: 90 minutes ]
  To evaluate the difference between the double product (the product of heart rate and systolic blood pressure);
• Angina [ Time Frame: 90 minutes ]
  To evaluate the difference between the presence of angina;

Original Secondary Outcome Measures (submitted: December 18, 2012)

• Mean heart rate [ Time Frame: 90 minutes ]
  To evaluate the difference between the mean heart rate;
• Systolic blood pressure [ Time Frame: 90 minutes ]
  To evaluate the difference between the systolic blood pressure;
• Diastolic blood pressure [ Time Frame: 90 minutes ]
  To evaluate the difference between the diastolic blood pressure;
• Double product [ Time Frame: 90 minutes ]
  To evaluate the difference between the double product;
• Angina [ Time Frame: 90 minutes ]
  To evaluate the difference between the presence of angina;

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Coronary Artery Disease

Intervention

• Behavioral: Soccer
  Watching the soccer match at the time that the favorite team is playing
• Behavioral: Movie
  Watching a movie at the time that the favorite team is playing

Study Arms

• Experimental: Soccer
  Watching the soccer match at the time that the favorite team is playing
  Intervention: Behavioral: Soccer
• Placebo Comparator: Movie
  Watching a movie at the time that the favorite team is playing
  Intervention: Behavioral: Movie

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 18, 2012): 17
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Coronary artery disease;
• Avai or Figueirense (brazilian soccer teams) fans

Exclusion Criteria:

• Acute coronary syndrome in less than 7 days

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01754675
• Other Study ID Numbers: CAAE: 03807212.5.0000.0113
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
• Study Sponsor: Instituto de Cardiologia de Santa Catarina
• Collaborators: Not Provided

Investigators

• Study Chair: Daniel M Moreira, MD. MSc.; Instituto de Cardiologia de Santa Catarina

• PRS Account: Instituto de Cardiologia de Santa Catarina
• Verification Date: December 2012