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Intracardiac Flow Remodeling in Athletes (INFINITE)

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ClinicalTrials.gov Identifier: NCT03076788
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date February 16, 2017
First Posted Date March 10, 2017
Last Update Posted Date August 6, 2019
Actual Study Start Date January 1, 2017
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2017)
Evaluation of ventricular response to exercise training by echocardiography. [ Time Frame: Day 1 ]
  1. 2D- morphological and functional parameters of both left and right ventricles:
    • end-diastolic and end-systolic dimensions (cm)
    • left ventricular mass (g)
    • ventricular end-diastolic and end-systolic areas (cm²)
    • ventricular ejection fraction (%)
    • atrial volumes (ml)
    • diastolic indices by pulsed wave Doppler and tissue Doppler (cm/s)
    • myocardial deformation by speckle tracking (%)
  2. 3D- morphological and functional parameters of both left and right ventricles:
    • ventricular full volumes (ml)
    • ejection fraction (%)
  3. Intracardiac flow measurements by color Doppler M-mode:
estimation of intra ventricular pressure gradients between the base and the apex (mmHg).
Original Primary Outcome Measures
 (submitted: March 6, 2017)
Evaluation of ventricular response to exercise training by echocardiography. [ Time Frame: at the time of the inclusion in the study ]
  1. 2D- morphological and functional parameters of both left and right ventricles:
    • end-diastolic and end-systolic dimensions (cm)
    • left ventricular mass (g)
    • ventricular end-diastolic and end-systolic areas (cm²)
    • ventricular ejection fraction (%)
    • atrial volumes (ml)
    • diastolic indices by pulsed wave Doppler and tissue Doppler (cm/s)
    • myocardial deformation by speckle tracking (%)
  2. 3D- morphological and functional parameters of both left and right ventricles:
    • ventricular full volumes (ml)
    • ejection fraction (%)
  3. Intracardiac flow measurements by color Doppler M-mode:
estimation of intra ventricular pressure gradients between the base and the apex (mmHg).
Change History Complete list of historical versions of study NCT03076788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 17, 2017)
  • Evaluation of ventricular response to exercise training by electrocardiogram [ Time Frame: Day 1 ]
    • heart rate (bpm),
    • ventricular hypertrophy (mV)
    • atrial remodeling (mV)
  • Sport and medical history questionnaire [ Time Frame: Day 1 ]
    exercise training program, medical past history, cardiovascular risk factors, treatments, doping.
Original Secondary Outcome Measures
 (submitted: March 6, 2017)
  • Evaluation of ventricular response to exercise training by electrocardiogram [ Time Frame: at the time of the inclusion in the study ]
    • heart rate (bpm),
    • ventricular hypertrophy (mV)
    • atrial remodeling (mV)
  • Sport and medical history questionnaire [ Time Frame: at the time of the inclusion in the study ]
    exercise training program, medical past history, cardiovascular risk factors, treatments, doping.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intracardiac Flow Remodeling in Athletes
Official Title Intracardiac Flow Remodeling in Athletes
Brief Summary The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Athletes
Condition Cardiac Remodeling, Ventricular
Intervention Other: electrocardiogram and echocardiography

We retrieved all electrocardiograms and echocardiography made during the clinical examination of each athlete and each sedentary control.

  • Standard 12 lead ECG
  • Trans-thoracic echocardiography examination of cardiac function, morphology and intracardiac flow.
Study Groups/Cohorts
  • Athletes

    Professional and amateur athletes examined during the medical follow-up at the medical sport centre of Caen University Hospital.

    The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography.

    Intervention: Other: electrocardiogram and echocardiography
  • Sedentary controls

    Sedentary patients assessed in the cardiology unit with a normal heart function.

    The medical examination consists in a clinical exam, an electrocardiogram and an echocardiography.

    Intervention: Other: electrocardiogram and echocardiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2017)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date January 1, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age > 18yrs old
  • Ability to give written consent for participating in the study

Exclusion Criteria:

  • Age < 18yrs old
  • Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03076788
Other Study ID Numbers 16-022.
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor University Hospital, Caen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Caen
Verification Date August 2019