- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656861
Lithuanian Atletes' Aortic Diameter
Lithuanian Athletes' Aortic Root Diameter
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
Non-athletes
29 were non-athletes (14 females and 15 males)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Changes 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)
Time Frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
|
Changes 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)
Time Frame: Long-term adaptation more when 4 years of physical activity with 4.5 hours per week training sessions
|
Changes values of 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kaunas Sport Medicine Centre
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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