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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
ClinicalTrials.gov Identifier:
NCT01754675
First received: December 18, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Behavioral: Soccer
Behavioral: Movie
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia de Santa Catarina:

Primary Outcome Measures:
  • Average mean arterial pressure [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    To evaluate the difference between the mean heart rate;

  • Systolic blood pressure [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    To evaluate the difference between the systolic blood pressure;

  • Diastolic blood pressure [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    To evaluate the difference between the diastolic blood pressure;

  • Double product [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    To evaluate the difference between the double product (the product of heart rate and systolic blood pressure);

  • Angina [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]
    To evaluate the difference between the presence of angina;


Enrollment: 17
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Soccer
Watching the soccer match at the time that the favorite team is playing
 Behavioral: Soccer
Watching the soccer match at the time that the favorite team is playing
Placebo Comparator: Movie
Watching a movie at the time that the favorite team is playing
 Behavioral: Movie
Watching a movie at the time that the favorite team is playing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute coronary syndrome in less than 7 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754675

Locations
Brazil
Instituto de Cardiologia de Santa Catarina
São José, Santa Catarina, Brazil
Sponsors and Collaborators
Instituto de Cardiologia de Santa Catarina
Investigators
Study Chair: Daniel M Moreira, MD. MSc. Instituto de Cardiologia de Santa Catarina
  More Information

No publications provided

Responsible Party: Daniel Medeiros Moreira, MD. MSc., Instituto de Cardiologia de Santa Catarina
ClinicalTrials.gov Identifier: NCT01754675     History of Changes
Other Study ID Numbers: CAAE: 03807212.5.0000.0113
Study First Received: December 18, 2012
Last Updated: December 20, 2012
Health Authority: Ethics Committee: Brazil

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013