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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754675
Recruitment Status : Completed
First Posted : December 21, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date December 24, 2012
Study Start Date  ICMJE May 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute coronary syndrome in less than 7 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754675
Other Study ID Numbers  ICMJE CAAE: 03807212.5.0000.0113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
Study Sponsor  ICMJE Instituto de Cardiologia de Santa Catarina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP