NCT03656861

Brief 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. 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

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

September 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 29, 2018

Last Update Submit

August 31, 2018

Conditions

Keywords

Aortic ValveSinus of ValsalvaEchocardiographySudden cardiac death

Outcome Measures

Primary Outcomes (2)

  • Measurement of aortic root at aortic valve annulus (AA)

    Changes in aortic root at aortic valve annulus (AA) and at individuals.

    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.

    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)

    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)

    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)

    Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions

Study Arms (2)

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.

Other: Physical load

Non-athletes

29 were non-athletes (14 females and 15 males)

Interventions

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.

Athletes

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 4, 2018

Study Start

September 1, 2014

Primary Completion

September 30, 2015

Study Completion

September 30, 2015

Last Updated

September 5, 2018

Record last verified: 2018-08