Cardiovascular DiseasesNCT03171285
Cardiovascular Disease in Soccer Referees
An observational study of Cardiovascular Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Although the mortality rate among soccer players is low, it causes much impact on the entire community and is a fascinating conundrum. The aim of this study was to evaluate the cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk considering age groups younger and older than 35… Read more about this study
- Who is it for?
- Ages 25 to 44 years, men only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Less than 35 years old and Greater than or equal to 35 years
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2009to 12 Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- Men only
- No healthy volunteers
- Adult
Study population: 50 high performance field soccer referees of the Paulista Soccer Federation (PFF), during a pre-season training period of the 2009 Brazilian soccer championship.
Who may be able to join
- elite referees of the gold series of the Paulista Soccer Federation;
- registered for participation in the São Paulo professional soccer championship in 2009;
- eligible for pre-participative evaluation and have completed the entire series of tests considered indispensable for the present study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
São Paulo, 03828-000
About this study
Official title: Risk of Cardiovascular Disease in Soccer Referees: a Cross Sectional Study
Although the mortality rate among soccer players is low, it causes much impact on the entire community and is a fascinating conundrum. The aim of this study was to evaluate the cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk considering age groups younger and older than 35 years old and to relate the Framingham and PROCAM indices for the comparison of cardiovascular risk in soccer referees. 50 referees of Paulista Soccer Federation were subjected to clinical and laboratory based evaluations at the Center for Sports Health at the Faculty of Medicine of ABC, and divided into two groups: lower and higher than 35 years of age.
Read the detailed description
This is a cross-sectional study performed in a non-probabilistic sample for convenience, derived from information collected from medical records of the Medical Statistics Service. Data were obtained through clinical evaluation information and subsidiary examinations of 50 high performance field soccer referees of the Paulista Soccer Federation (PFF), during a pre-season training period of the 2009 Brazilian soccer championship.
Emphasis was especially placed on exposure to risk factors for coronary artery disease, conceivably more responsible for sudden death, when congenital heart disease was excluded.
All subjects were acquiesced to clinical and laboratory evaluations at the Center for Health in Sport of the Faculty of Medicine of ABC (FMABC). The referees were split into two age groups, according to the median of their ages. One of the groups consisted of trained individuals < 35 years old while the other group was made up of referees > 35 years old.
Family history: Occurrence of one or more relatives with disease or death from cardiac disease aged less than 50 years; Report of cardiomyopathy, coronary artery disease, Marfan syndrome or long QT syndrome, severe cardiac arrhythmias, or other cardiovascular diseases.
Personal history: Syncope or pre-Syncope; Chest pain or discomfort; Lack of air or fatigue disproportionate to the effort made; Palpitations or irregular heartbeat.
Physical examination: Physical and/or ocular signs of Marfan Syndrome; Decreased femoral artery pulses or "tardus"; meso- or telo- systolic murmurs; Second abnormal heart sound (single or with fixed unfolding with breathing); Heart murmurs (grade 2/6 systolic or diastolic of any intensity); Irregular heart rate; Bilateral blood pressure greater than 140/90 mmHg in more than one measurement.
Biochemical tests: High density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoproteins (VLDL), triglycerides (TG) and fasting blood glucose levels (Glic) were analyzed. The biochemical blood tests were processed by the Clinical Laboratory of FMABC, certified by controlab and ANVISA. The reference standards were considered according to the Guidelines of the Brazilian Society of Cardiology.
Ergospirometry: The following parameters were analyzed: Ergospirometry (Ergo), Maximum heart rate (HRmax), Maximum oxygen consumption (VO2max) and Anaerobic threshold (LA). The ergospirometric data were obtained through the Centurion 200 Treadmill and Micromed® BRA ECG. Protocol: start with 10 km/h - 1% inclination and increase of 1 km every minute. Gas analyzer: Vmax, Encore 29 c, Sensormedics®, USA. Program 20-21. Gases in two torpedoes: (1) - oxygen (O2); 26% and (2) - Carbon Dioxide (CO2): 4%, oxygen (O2) = 16% and Nitrogen (N2).
Echocardiogram: Two-dimensional echocardiogram (ECO) with Doppler was obtained by Esaote® model AV3 Partner with 2.5 MHz transducer with color flow mapping.
Electrocardiogram: The electrocardiographic tracings were performed by the Ecafix® CardioPerfect 5.0 device coupled to a microcomputer with compatible HD and a 1.4 MB drive 60 Hz filter. Approved by the Food and Drug Administration (FDA), the records were taken at rest, on days when they had not performed exercises, and according to the best clinical practice. The interpretation of the ECG abnormalities was completed by an experienced specialist and according to the criteria established by Corrado et al., for which they were classified into two categories:
- Group 1: commonly observed in trained athletes (over 80%) sinus bradycardia, first-degree AV block, V1 notch QRS or incomplete right bundle branch block, early repolarization, LVH criteria according to voltage increase in V5 and V6 consistent with the athlete's age, ethnicity and degree of physical fitness, and which does not require additional testing.
- Group 2: less common ECG changes (less than 5%) and need to be better evaluated to exclude cardiovascular diseases: T-wave inversion, ST-segment depression, pathological Q-waves, left atrial enlargement, QRS shift to the left, left/right anterolateral hemiblock, right QRS deviation/left posterolateral lower hemiblock, right ventricular hypertrophy, complete left or right bundle branch block, long or short QT interval, early ventricular repolarization Brugada like, ventricular arrhythmias.
Framingham and PROCAM indexes The risk of developing cardiovascular disease is contingent on multiple variables that interrelate with each other, increasing the probability of developing atherosclerotic coronary disease. Each of the risk factors is assigned a value that reflects greater or lesser potential impact on the development of cardiovascular disease and the implementation of preventive measures, and likelihoods, when applied early, to avert the onset of this disease.
The Framingham risk index was constructed based on the Framingham study, a prospective observational survey developed in the small northeastern city of the United States of America. This study evaluated blood pressure, smoking, lipid profile and other characteristics of 5,300 individuals of different ethnicities residing in Framingham, aged between 30 and 74 years at the time of the initial observation, as well as their causes of death and disease.
This index analyzes the cardiovascular risk in relation to the chance of developing stroke, acute myocardial infarction and cardiovascular death for the subsequent 10 years. The Framingham cardiovascular risk index has the characteristic of categorizing the variables into a smaller number of sections or sections without significant differentiation of body mass, age, gender, total cholesterol, HDL, presence or absence of smoking and Diabetes Mellitus, systolic and diastolic blood pressure values. Total points represent the percentage of cardiovascular risk (acute myocardial infarction, stroke and cardiovascular death) in the following 10 years.
The PROCAM index is a cardiovascular risk index based on a European study that commenced in 1979 and was completed in 1985. A total of 5159 individuals, all males, aged 35 to 65 years. The PROCAM index identified the following variables: age, LDL-cholesterol, HDL-cholesterol, Triglycerides (this is the only criterion that considers it directly), smoking, Diabetes Mellitus, systolic blood pressure and family history (this variable is considered only by this risk score). The total points represent the risk of cardiovascular disease (acute myocardial infarction, stroke and cardiovascular death) in the ensuing 10 years.
- Conditions
- Cardiovascular Diseases
- Being tested
- Less than 35 years old, Greater than or equal to 35 years
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less than 35 years oldOther
Clinical and laboratory evaluations
Greater than or equal to 35 yearsOther
Clinical and laboratory evaluations
| Study group | Role | What they receive |
|---|---|---|
| Less than 35 years old | Clinical and laboratory evaluations Receives: Other: Less than 35 years old | |
| Greater than or equal to 35 years | Clinical and laboratory evaluations Receives: Other: Greater than or equal to 35 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Higher risk for coronary artery disease in referees aged over 35 years old.
Higher risk for coronary artery disease in referees aged over 35 years old assessed by clinical and laboratory evaluations.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start2 May 2009
- Primary completion12 Dec 2009
- Study completion12 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171285
- Sponsor's protocol ID
- 038/2011
- Status last verified
- May 2017
- First submitted
- 27 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Cardiovascular Disease in Soccer Referees: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03171285
- Acronym / sponsor ID
- 038/2011
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 May 2009 (actual)
- Primary completion
- 12 Dec 2009 (actual)
- Study completion
- 12 Dec 2009 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the mortality rate among soccer players is low, it causes much impact on the entire community and is a fascinating conundrum. The aim of this study was to evaluate the cardiovascular risk of soccer referees, to describe the frequency of cardiovascular risk considering age groups younger and older than 35 years old and to relate the Framingham and PROCAM indices for the comparison of cardiovascular risk in soccer referees. 50 referees of Paulista Soccer Federation were subjected to clinical and laboratory based evaluations at the Center for Sports Health at the Faculty of Medicine of ABC, and divided into two groups: lower and higher than 35 years of age.
Detailed description
This is a cross-sectional study performed in a non-probabilistic sample for convenience, derived from information collected from medical records of the Medical Statistics Service. Data were obtained through clinical evaluation information and subsidiary examinations of 50 high performance field soccer referees of the Paulista Soccer Federation (PFF), during a pre-season training period of the 2009 Brazilian soccer championship.
Emphasis was especially placed on exposure to risk factors for coronary artery disease, conceivably more responsible for sudden death, when congenital heart disease was excluded.
All subjects were acquiesced to clinical and laboratory evaluations at the Center for Health in Sport of the Faculty of Medicine of ABC (FMABC). The referees were split into two age groups, according to the median of their ages. One of the groups consisted of trained individuals < 35 years old while the other group was made up of referees > 35 years old.
Family history: Occurrence of one or more relatives with disease or death from cardiac disease aged less than 50 years; Report of cardiomyopathy, coronary artery disease, Marfan syndrome or long QT syndrome, severe cardiac arrhythmias, or other cardiovascular diseases.
Personal history: Syncope or pre-Syncope; Chest pain or discomfort; Lack of air or fatigue disproportionate to the effort made; Palpitations or irregular heartbeat.
Physical examination: Physical and/or ocular signs of Marfan Syndrome; Decreased femoral artery pulses or "tardus"; meso- or telo- systolic murmurs; Second abnormal heart sound (single or with fixed unfolding with breathing); Heart murmurs (grade 2/6 systolic or diastolic of any intensity); Irregular heart rate; Bilateral blood pressure greater than 140/90 mmHg in more than one measurement.
Biochemical tests: High density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoproteins (VLDL), triglycerides (TG) and fasting blood glucose levels (Glic) were analyzed. The biochemical blood tests were processed by the Clinical Laboratory of FMABC, certified by controlab and ANVISA. The reference standards were considered according to the Guidelines of the Brazilian Society of Cardiology.
Ergospirometry: The following parameters were analyzed: Ergospirometry (Ergo), Maximum heart rate (HRmax), Maximum oxygen consumption (VO2max) and Anaerobic threshold (LA). The ergospirometric data were obtained through the Centurion 200 Treadmill and Micromed® BRA ECG. Protocol: start with 10 km/h - 1% inclination and increase of 1 km every minute. Gas analyzer: Vmax, Encore 29 c, Sensormedics®, USA. Program 20-21. Gases in two torpedoes: (1) - oxygen (O2); 26% and (2) - Carbon Dioxide (CO2): 4%, oxygen (O2) = 16% and Nitrogen (N2).
Echocardiogram: Two-dimensional echocardiogram (ECO) with Doppler was obtained by Esaote® model AV3 Partner with 2.5 MHz transducer with color flow mapping.
Electrocardiogram: The electrocardiographic tracings were performed by the Ecafix® CardioPerfect 5.0 device coupled to a microcomputer with compatible HD and a 1.4 MB drive 60 Hz filter. Approved by the Food and Drug Administration (FDA), the records were taken at rest, on days when they had not performed exercises, and according to the best clinical practice. The interpretation of the ECG abnormalities was completed by an experienced specialist and according to the criteria established by Corrado et al., for which they were classified into two categories:
- Group 1: commonly observed in trained athletes (over 80%) sinus bradycardia, first-degree AV block, V1 notch QRS or incomplete right bundle branch block, early repolarization, LVH criteria according to voltage increase in V5 and V6 consistent with the athlete's age, ethnicity and degree of physical fitness, and which does not require additional testing.
- Group 2: less common ECG changes (less than 5%) and need to be better evaluated to exclude cardiovascular diseases: T-wave inversion, ST-segment depression, pathological Q-waves, left atrial enlargement, QRS shift to the left, left/right anterolateral hemiblock, right QRS deviation/left posterolateral lower hemiblock, right ventricular hypertrophy, complete left or right bundle branch block, long or short QT interval, early ventricular repolarization Brugada like, ventricular arrhythmias.
Framingham and PROCAM indexes The risk of developing cardiovascular disease is contingent on multiple variables that interrelate with each other, increasing the probability of developing atherosclerotic coronary disease. Each of the risk factors is assigned a value that reflects greater or lesser potential impact on the development of cardiovascular disease and the implementation of preventive measures, and likelihoods, when applied early, to avert the onset of this disease.
The Framingham risk index was constructed based on the Framingham study, a prospective observational survey developed in the small northeastern city of the United States of America. This study evaluated blood pressure, smoking, lipid profile and other characteristics of 5,300 individuals of different ethnicities residing in Framingham, aged between 30 and 74 years at the time of the initial observation, as well as their causes of death and disease.
This index analyzes the cardiovascular risk in relation to the chance of developing stroke, acute myocardial infarction and cardiovascular death for the subsequent 10 years. The Framingham cardiovascular risk index has the characteristic of categorizing the variables into a smaller number of sections or sections without significant differentiation of body mass, age, gender, total cholesterol, HDL, presence or absence of smoking and Diabetes Mellitus, systolic and diastolic blood pressure values. Total points represent the percentage of cardiovascular risk (acute myocardial infarction, stroke and cardiovascular death) in the following 10 years.
The PROCAM index is a cardiovascular risk index based on a European study that commenced in 1979 and was completed in 1985. A total of 5159 individuals, all males, aged 35 to 65 years. The PROCAM index identified the following variables: age, LDL-cholesterol, HDL-cholesterol, Triglycerides (this is the only criterion that considers it directly), smoking, Diabetes Mellitus, systolic blood pressure and family history (this variable is considered only by this risk score). The total points represent the risk of cardiovascular disease (acute myocardial infarction, stroke and cardiovascular death) in the ensuing 10 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less than 35 years old | – | Other: Less than 35 years oldClinical and laboratory evaluations |
| Greater than or equal to 35 years | – | Other: Greater than or equal to 35 yearsClinical and laboratory evaluations |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 50 high performance field soccer referees of the Paulista Soccer Federation (PFF), during a pre-season training period of the 2009 Brazilian soccer championship.
Key inclusion criteria (3 listed)
- elite referees of the gold series of the Paulista Soccer Federation;
- registered for participation in the São Paulo professional soccer championship in 2009;
- eligible for pre-participative evaluation and have completed the entire series of tests considered indispensable for the present study.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Less than 35 years oldClinical and laboratory evaluations | Other | Less than 35 years old |
| Greater than or equal to 35 yearsClinical and laboratory evaluations | Other | Greater than or equal to 35 years |
Primary outcome
Higher risk for coronary artery disease in referees aged over 35 years old.
Time frame: 7 months
Higher risk for coronary artery disease in referees aged over 35 years old assessed by clinical and laboratory evaluations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher risk for coronary artery disease in referees aged over 35 years old. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.