NCT01754675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
Last Updated

December 24, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

December 18, 2012

Last Update Submit

December 20, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Mean heart rate

    90 minutes

  • Systolic blood pressure

    90 minutes

  • Diastolic blood pressure

    90 minutes

  • Double product

    90 minutes

  • Angina

    90 minutes

Study Arms (2)

Soccer

EXPERIMENTAL

Watching the soccer match at the time that the favorite team is playing

Behavioral: Soccer

Movie

PLACEBO COMPARATOR

Watching a movie at the time that the favorite team is playing

Behavioral: Movie

Interventions

SoccerBEHAVIORAL

Watching the soccer match at the time that the favorite team is playing

Soccer
MovieBEHAVIORAL

Watching a movie at the time that the favorite team is playing

Movie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Acute coronary syndrome in less than 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Cardiologia de Santa Catarina

São José, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Motion Pictures

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Audiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Daniel M Moreira, MD. MSc.

    Instituto de Cardiologia de Santa Catarina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. MSc.

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 21, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 24, 2012

Record last verified: 2012-12

Locations