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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01754675
Other study ID # CAAE: 03807212.5.0000.0113
Secondary ID
Status Completed
Phase Phase 2
First received December 18, 2012
Last updated December 20, 2012
Start date May 2012
Est. completion date August 2012

Study information

Verified date December 2012
Source Instituto de Cardiologia de Santa Catarina
Contact n/a
Is FDA regulated No
Health authority Ethics Committee: Brazil
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Coronary artery disease;

- Avai or Figueirense (brazilian soccer teams) fans

Exclusion Criteria:

- Acute coronary syndrome in less than 7 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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

Locations

Country Name City State
Brazil Instituto de Cardiologia de Santa Catarina São José Santa Catarina

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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; 90 minutes No
Secondary Mean heart rate To evaluate the difference between the mean heart rate; 90 minutes No
Secondary Systolic blood pressure To evaluate the difference between the systolic blood pressure; 90 minutes No
Secondary Diastolic blood pressure To evaluate the difference between the diastolic blood pressure; 90 minutes No
Secondary Double product To evaluate the difference between the double product (the product of heart rate and systolic blood pressure); 90 minutes No
Secondary Angina To evaluate the difference between the presence of angina; 90 minutes Yes
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