Myocardial Mechanics in Athlete's Heart

August 29, 2023 updated by: PACE Nathalie, Central Hospital, Nancy, France

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

Completed

Conditions

Detailed Description

Healthy male athletes belonging to local clubs, who underwent a pre-participation medical evaluation at the University Hospital of Nancy between 2013 and 2020, will be screened. Clinical, echocardiographic and cardiopulmonary exercise testing data will be compared to a group of healthy men from the STANISLAS cohort. Subtle LV dysfunction will be defined by a GLS <17.5%.

Study Type

Observational

Enrollment (Actual)

191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nancy, France, 54000
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Cross-sectional study, using data from young high-performance athletes referred to the cardiologic department of Nancy University Hospital for a pre-participation medical evaluation.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nathalie Pace, MD, CHRU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.To achieve aims in the approved proposal. Proposals should be directed to n.pace@chru-nancy.fr.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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