The general objective of ELITE is to establish a cardiac baseline of all NOC*NSF elite athletes, and to investigate changes in cardiac indices over time. The cardiac baseline includes cardiovascular screening using established diagnostic tools, as…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of ELITE is to establish comprehensive cardiac baseline
assessment in elite athletes consisting of electrocardiologic characteristics,
VO2 max, peak load (in METS or Watt), cardiac biomarkers, lipid profile,
ejection fraction (EF), wall thickness of the left and right ventricle, volume
of left- and right atria and ventricles, myocardial tissue characteristics
including fibrosis using late gadolinium enhancement (LGE), strain of left- and
right ventricle, quantification of body composition, and cardiogenetics.
Secondary outcome
na
Background summary
Sudden cardiac arrest (SCA) is the leading medical cause of death in young
athletes.1 While SCA is a rare event, the impact on athletes, their family and
surroundings, professionals in sports, and society at large is devastating.
Unfortunately, current prevention of SCA in athletes is far from optimal.
Limited studies have investigated specific causes of SCA and sudden cardiac
death (SCD) in athletes, most studies in sports cardiology are cross-sectional
and have used older diagnostic modalities. In addition, little is known about
the prognostic implications of possible (minor) abnormalities detected at
screening. Furthermore, there is an unmet need to provide advice and specific
sports advice in individuals with potentially pathogenic genotypes without
signs of specific phenotypes. To answer these questions, prospectively defined
cohort studies with extensive baseline data and longitudinal follow-up
measurements beyond baseline examinations are needed.2 Therefore, we aim to
establish ELITE (Evaluation of Lifetime participation in Intense Top-level
sports and Exercise). With this cohort we investigate the cardiac baselines and
effects of intensive top-level sports and exercise, and the development of
cardiac pathology.
Study objective
The general objective of ELITE is to establish a cardiac baseline of all
NOC*NSF elite athletes, and to investigate changes in cardiac indices over
time. The cardiac baseline includes cardiovascular screening using established
diagnostic tools, as well as advanced cardiac imaging. Additionally, we aim to
establish an elite athlete DNA biobank (for cardiogenetic analyses).
Study design
ELITE is a prospective, longitudinal cohort study and will contain data of the
coupled SMART screening. The SMART screening has been established as usual care
for all elite athletes according to NOC*NSF and consists of physician
consultation, training and injury data (as collected in NOC*NSF athlete
management system Smartabase), physical examination, electrocardiogram (ECG),
cardiopulmonary exercise test (CPX), laboratory measurements ,transthoracic
echocardiogram (TTE) and cardiac magnetic resonance imaging (CMR). In addition
to the data collected at the SMART screening, ELITE will include blood for
biobanking, to be used for cardiogenetic analyses. After baseline measurements,
follow-up is planned at 2-5 year intervals according to age, and at 5-year
intervals after cessation of a professional sports career.
Study burden and risks
ELITE is an observational study, collecting data from cardiovascular screenings
that are performed as part of usual care (SMART screening) in addition to the
ELITE biobank. No adverse or serious adverse events are expected from
participation in the cohort, and there is no direct benefit for the
participants. Screening results will be treated according to separate screening
protocols (usual care). Due to the extensive health examination, potential
benefit may be derived from early detection of diseases, as is the objective of
the screening.
Meibergdreef 9
Amsterdam 1105HZ
NL
Meibergdreef 9
Amsterdam 1105HZ
NL
Listed location countries
Age
Inclusion criteria
>16 years old
Registered as elite athletes according to NOC*NSF (A-status, HP-status or
selection status)
Participation in the SMART screening
Exclusion criteria
Unable to give inform consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL71682.018.19 |
OMON | NL-OMON21171 |