- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543525
Myocardial Mechanics in Athlete's Heart
Advanced Myocardial Deformation Echocardiography for the Athlete's Heart Evaluation: Functional and Mechanistic Analysis
Echocardiographic assessment of the endurance athletes' heart remains challenging due to a phenotypic overlap between reactive physiological adaptation and pathological remodelling. The lower range of normal values of lLeft ventricle systolic ejection fraction (LVEF) and global longitudinal strain (GLS) in athletes makes it difficult to differentiate changes related to adaptive remodelling or indicative of early cardiomyopathy.
This study aims to improve the assessment of athletes' hearts by identifying echocardiographic phenotypes, using a speckle tracking including temporal deformation pattern and layer-specific approach, and to define predictive factors of subtle LV systolic dysfunction and of mechanical LV abnormalities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nancy, France, 54000
- CHRU Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- athletes who underwent a pre-participation medical evaluation in the Nancy University Hospital between January 1st, 2013, and January 1st, 2020
Exclusion Criteria:
- female athletes,
- athletes followed for cardiomyopathy
- athletes who did not have transthoracic echocardiography (TTE) performed.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Male Athletes
Athletes who underwent a pre-participation medical evaluation in the Nancy University Hospital between January 1st, 2013, and January 1st, 2020.
|
Transthoracic echocardiography
Cardiopulmonary exercise testing
|
Control Group
A subgroup of 161 participants in a population-based cohort (STANISLAS Cohort) restricted by age and sex to create a control group in the current analysis.
|
Transthoracic echocardiography
Cardiopulmonary exercise testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multilayer (= epi- and endocardial) left ventricular global longitudinal strain using Speckle-tracking echocardiography
Time Frame: Baseline
|
expressed in %
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age
Time Frame: Baseline
|
years
|
Baseline
|
Height
Time Frame: baseline
|
meter
|
baseline
|
Weight
Time Frame: baseline
|
meter
|
baseline
|
BMI
Time Frame: baseline
|
kg/m²
|
baseline
|
Heart rate
Time Frame: baseline
|
bpm
|
baseline
|
Left ventricle indexed mass
Time Frame: baseline
|
g/m²
|
baseline
|
Left ventricular Ejection Fraction
Time Frame: baseline
|
using simpson's biplane method, expressed in %
|
baseline
|
left ventricular End-diastolic volume
Time Frame: baseline
|
ml
|
baseline
|
Cardiac Index
Time Frame: baseline
|
ml/min/m²
|
baseline
|
Maximal E-wave velocity and Maximal A-wave velocity
Time Frame: baseline
|
m/s
|
baseline
|
Left atrium End-systolic volume
Time Frame: baseline
|
ml/m²
|
baseline
|
left ventricular global longitudinal strain (peak G) assessed by Speckle-tracking echocardiography
Time Frame: baseline
|
expressed in %
|
baseline
|
PSI (pre stretch index) assessed by Speckle-tracking echocardiography
Time Frame: baseline
|
expressed in %
|
baseline
|
PST (postsystolic thickening) assessed by Speckle-tracking echocardiography
Time Frame: baseline
|
expressed in %
|
baseline
|
Peak VO2
Time Frame: baseline
|
L/min
|
baseline
|
Type of practiced sport
Time Frame: baseline
|
soccer, basketball, handball
|
baseline
|
Inter ventricular septum diameter
Time Frame: baseline
|
mm
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathalie Pace, MD, CHRU Nancy
Publications and helpful links
General Publications
- Spirito P, Pelliccia A, Proschan MA, Granata M, Spataro A, Bellone P, Caselli G, Biffi A, Vecchio C, Maron BJ. Morphology of the "athlete's heart" assessed by echocardiography in 947 elite athletes representing 27 sports. Am J Cardiol. 1994 Oct 15;74(8):802-6. doi: 10.1016/0002-9149(94)90439-1.
- Caselli S, Maron MS, Urbano-Moral JA, Pandian NG, Maron BJ, Pelliccia A. Differentiating left ventricular hypertrophy in athletes from that in patients with hypertrophic cardiomyopathy. Am J Cardiol. 2014 Nov 1;114(9):1383-9. doi: 10.1016/j.amjcard.2014.07.070. Epub 2014 Aug 12.
- Schnell F, Matelot D, Daudin M, Kervio G, Mabo P, Carre F, Donal E. Mechanical Dispersion by Strain Echocardiography: A Novel Tool to Diagnose Hypertrophic Cardiomyopathy in Athletes. J Am Soc Echocardiogr. 2017 Mar;30(3):251-261. doi: 10.1016/j.echo.2016.11.013. Epub 2017 Jan 5.
- Abuli M, de la Garza MS, Sitges M. Differentiating Athlete's Heart from Left Ventricle Cardiomyopathies. J Cardiovasc Transl Res. 2020 Jun;13(3):265-273. doi: 10.1007/s12265-020-10021-8. Epub 2020 May 14.
- Santoro A, Alvino F, Antonelli G, Caputo M, Padeletti M, Lisi M, Mondillo S. Endurance and Strength Athlete's Heart: Analysis of Myocardial Deformation by Speckle Tracking Echocardiography. J Cardiovasc Ultrasound. 2014 Dec;22(4):196-204. doi: 10.4250/jcu.2014.22.4.196. Epub 2014 Dec 26.
- D'Ascenzi F, Solari M, Mazzolai M, Cameli M, Lisi M, Andrei V, Focardi M, Bonifazi M, Mondillo S. Two-dimensional and three-dimensional left ventricular deformation analysis: a study in competitive athletes. Int J Cardiovasc Imaging. 2016 Dec;32(12):1697-1705. doi: 10.1007/s10554-016-0961-6. Epub 2016 Aug 13.
- Huttin O, Girerd N, Coiro S, Bozec E, Selton-Suty C, Lamiral Z, Frikha Z, Kobayashi M, Argulian E, Narula J, Fraser AG, Rossignol P, Zannad F. Association Between Layer-Specific Longitudinal Strain and Risk Factors of Heart Failure and Dyspnea: A Population-Based Study. J Am Soc Echocardiogr. 2019 Jul;32(7):854-865.e8. doi: 10.1016/j.echo.2019.03.011. Epub 2019 May 16.
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
Keywords
Other Study ID Numbers
- 2022PI064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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