Sports AccidentNCT03656861
Lithuanian Atletes' Aortic Diameter
An observational study of Sports Accident and Athletes Heart, run by Agne Slapsinskaite.
Trial summary
Recent developments in football have seen the sudden death of young football player due to aortic rupture hence reinforcing the controversy of football as a field with substantial risk for sudden cardiac arrest and death. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Accident, Athletes Heart
- What is being tested?
- Physical load
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 30 Sep 2015
- 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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The subjects were divided into groups according to gender (i.e., female, male), physical activity (i.e., athletes, non-athletes) and physical activity type (i.e., strength and endurance sports). Of the 151 subjects, 122 were athletes (41 females and 81 males) and 29 were non-athletes (14 females and 15 males). Of the 41 female athletes, 32 were endurance athletes, and 9 strength athletes. From 81 male athletes, 56 were endurance athletes, and 25 were strength athletes.
Who may be able to join
- A total of 2D transthoracic echocardiography performed in Kaunas Sports Medicine Centre 2014-2015.
- Age range 16- 35 years, given the literature definition of 'young' and 'old' athletes as < 35 and > 35 years.
- Physical activity levels (athletes or non-athletes). Individuals who participated in sports for more than 4 years and 4.5 hours per week were included in the group of athletes. Individual who were active for less than 4 years and/or 4.5 hours per week were classified as non-athletes.
- Physical activity type (endurance and strength sports).
- No current or previous history cardiovascular diseases.
- No activity on the test day.
- Consent to participate in the study.
Who cannot join
- No 2D transthoracic echocardiography.
- Age below 16 or over 35.
- Involvement in sports for less than 4 years and 4.5 hours per week.
- Sports branches not included in the list of endurance or strength sports (i.e., sprint, high jump, etc.).
- Cardiovascular disease (i.e., hypertonic disease, Marfan syndrome, bicuspid aortic valve, detected cardiomyopathy, etc.).
- Physical activity on the echocardiography test day.
- No content to participate in the study.
About this study
Official title: Lithuanian Athletes' Aortic Root Diameter
Recent developments in football have seen the sudden death of young football player due to aortic rupture hence reinforcing the controversy of football as a field with substantial risk for sudden cardiac arrest and death. Moreover, there is an argument that aortic dilatation and the subsequent event of thoracic aortic aneurysm may be an occupational disease due to the nature of some vocations (i.e., military and security personnel, blue collar workers, weightlifters, athletes etc.). Of particular importance, there is some evidence that elite athletic training is associated with small but significantly larger aortic root diameter. The purpose of this study was to investigate aortic root adaptation to physical workload and to determine if aortic root's and left ventricle sizes are contingent upon the physical workload
Read the detailed description
A preliminary data was collected from a total of 944 subjects in Kaunas Sports Medicine Centre during the recruiting period in 2014-2015. Final data analysis consisted of 151 Caucasian subjects who met the inclusion criteria.
All subjects underwent two-dimensional (2D) transthoracic echocardiography (TTE) procedure. Prior to performing 2D TTE, subjects' arterial blood pressure, heart rate, height, weight, and self-reported physical activity levels were measured.
The Ultrasound system CX50 (Philips Ultrasound, Philips Healthcare, Philips Medical Systems Nederland, USA) - with transducer S5-1 was used in this study. Two physicians performed 2D TTE and averages for all variables of interest were computed. The measurements of aortic root and the left ventricle were drawn upon the guidelines of the American Society of Echocardiography and the European Association of Cardiovascular Imaging.
The maximal diameter of the sinuses of Valsalva was measured at end-diastole, in a strictly perpendicular plane to that of the long axis of the aorta using the edge to leading edge (L-L) convention. The aortic annulus was measured at midsystole from inner edge to inner edge (I-I). This was done in order to obtain the rounder shape and bigger diameter of aortic annulus.
- Conditions
- Sports Accident, Athletes Heart
- Being tested
- Physical load
- Keywords
- Aortic Valve, Sinus of Valsalva, Echocardiography, Sudden cardiac death
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical loadOther
The impact of training on cardiac structure and function depends on the type, intensity and duration of the activity, as well as previous physical activity engagement, genetics and gender type. More knowledge about cardiac pathophysiologic training adaptation is needed.
| Study group | Role | What they receive |
|---|---|---|
| Athletes | 122 were athletes (41 females and 81 males). Of the 41 female athletes, 32 were endurance athletes, and 9 strength athletes. From 81 male athletes, 56 were endurance athletes, and 25 were strength athletes. Receives: Other: Physical load | |
| Non-athletes | 29 were non-athletes (14 females and 15 males) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of aortic root at aortic valve annulus (AA)
Changes in aortic root at aortic valve annulus (AA) and at individuals.
Measured: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Measurement of aortic root at sinus of Valsalva (VS)
Changes in aortic root at sinus of Valsalva (VS) individuals.
Measured: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Secondary outcomes (3)
Measurement of values of the left ventricle (LV): LV end-diastolic diameter (LVEDD)
Changes values of the left ventricle (LV): LV end-diastolic diameter (LVEDD)
Measured: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Measurement of values of interventricular septum thickness in diastole (IVSTd)
Changes values of interventricular septum thickness in diastole (IVSTd)
Measured: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
LV posterior wall thickness in diastole (LVPWTd)
Changes values of LV posterior wall thickness in diastole (LVPWTd)
Measured: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Sep 2014
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports AccidentStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agne Slapsinskaite
- Sponsor type
- University, hospital or other
- Collaborators
- Renata Žumbakytė-Šermukšnienė, Baranauskaitė Miglė, Berškienė Kristina
- Responsible party
- Sponsor-investigator, Agne Slapsinskaite, Institut Nacional d'Educacio Fisica de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656861
- Sponsor's protocol ID
- Kaunas Sport Medicine Centre
- Status last verified
- Aug 2018
- First submitted
- 29 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lithuanian Athletes' Aortic Root Diameter
- ClinicalTrials.gov ID
- NCT03656861
- Acronym / sponsor ID
- Kaunas Sport Medicine Centre
- Conditions
- Sports Accident, Athletes Heart
- Keywords
- Aortic Valve, Sinus of Valsalva, Echocardiography, Sudden cardiac death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Agne SlapsinskaiteUniversity, hospital or other
- Collaborators
- Renata Žumbakytė-Šermukšnienė, Baranauskaitė Miglė, Berškienė Kristina
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 4 Sep 2018 (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.
Recent developments in football have seen the sudden death of young football player due to aortic rupture hence reinforcing the controversy of football as a field with substantial risk for sudden cardiac arrest and death. Moreover, there is an argument that aortic dilatation and the subsequent event of thoracic aortic aneurysm may be an occupational disease due to the nature of some vocations (i.e., military and security personnel, blue collar workers, weightlifters, athletes etc.). Of particular importance, there is some evidence that elite athletic training is associated with small but significantly larger aortic root diameter. The purpose of this study was to investigate aortic root adaptation to physical workload and to determine if aortic root's and left ventricle sizes are contingent upon the physical workload
Detailed description
A preliminary data was collected from a total of 944 subjects in Kaunas Sports Medicine Centre during the recruiting period in 2014-2015. Final data analysis consisted of 151 Caucasian subjects who met the inclusion criteria.
All subjects underwent two-dimensional (2D) transthoracic echocardiography (TTE) procedure. Prior to performing 2D TTE, subjects' arterial blood pressure, heart rate, height, weight, and self-reported physical activity levels were measured.
The Ultrasound system CX50 (Philips Ultrasound, Philips Healthcare, Philips Medical Systems Nederland, USA) - with transducer S5-1 was used in this study. Two physicians performed 2D TTE and averages for all variables of interest were computed. The measurements of aortic root and the left ventricle were drawn upon the guidelines of the American Society of Echocardiography and the European Association of Cardiovascular Imaging.
The maximal diameter of the sinuses of Valsalva was measured at end-diastole, in a strictly perpendicular plane to that of the long axis of the aorta using the edge to leading edge (L-L) convention. The aortic annulus was measured at midsystole from inner edge to inner edge (I-I). This was done in order to obtain the rounder shape and bigger diameter of aortic annulus.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | Other: Physical load122 were athletes (41 females and 81 males). Of the 41 female athletes, 32 were endurance athletes, and 9 strength athletes. From 81 male athletes, 56 were endurance athletes, and 25 were strength athletes. |
| Non-athletes | – | –29 were non-athletes (14 females and 15 males) |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The subjects were divided into groups according to gender (i.e., female, male), physical activity (i.e., athletes, non-athletes) and physical activity type (i.e., strength and endurance sports). Of the 151 subjects, 122 were athletes (41 females and 81 males) and 29 were non-athletes (14 females and 15 males). Of the 41 female athletes, 32 were endurance athletes, and 9 strength athletes. From 81 male athletes, 56 were endurance athletes, and 25 were strength athletes.
Key inclusion criteria (7 listed)
- A total of 2D transthoracic echocardiography performed in Kaunas Sports Medicine Centre 2014-2015.
- Age range 16- 35 years, given the literature definition of 'young' and 'old' athletes as < 35 and > 35 years.
- Physical activity levels (athletes or non-athletes). Individuals who participated in sports for more than 4 years and 4.5 hours per week were included in the group of athletes. Individual who were active for less than 4 years and/or 4.5 hours per week were classified as non-athletes.
- Physical activity type (endurance and strength sports).
- No current or previous history cardiovascular diseases.
Key exclusion criteria (7 listed)
- No 2D transthoracic echocardiography.
- Age below 16 or over 35.
- Involvement in sports for less than 4 years and 4.5 hours per week.
- Sports branches not included in the list of endurance or strength sports (i.e., sprint, high jump, etc.).
- Cardiovascular disease (i.e., hypertonic disease, Marfan syndrome, bicuspid aortic valve, detected cardiomyopathy, etc.).
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 |
|---|---|---|
| Physical loadThe impact of training on cardiac structure and function depends on the type, intensity and duration of the activity, as well as previous physical activity engagement, genetics and gender type. More knowledge about cardiac pathophysiologic training adaptation is needed. | Other | Athletes |
Primary outcome
Measurement of aortic root at aortic valve annulus (AA)
Time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Changes in aortic root at aortic valve annulus (AA) and at individuals.
Measurement of aortic root at sinus of Valsalva (VS)
Time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Changes in aortic root at sinus of Valsalva (VS) individuals.
3 secondary outcomes
Measurement of values of the left ventricle (LV): LV end-diastolic diameter (LVEDD)
Time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
Measurement of values of interventricular septum thickness in diastole (IVSTd)
Time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
LV posterior wall thickness in diastole (LVPWTd)
Time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
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 5 Sep 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sports Accident and Athletes Heart, run by Agne Slapsinskaite.
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 7 inclusion and 7 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Measurement of aortic root at aortic valve annulus (AA) (time frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions). The study lists 2 primary outcomes in all. 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 5 Sep 2018.