Healthy Clinical Trial
Official title:
The North Sea Race Endurance Exercise Study
Competitions such as marathon running and endurance cycling events are increasingly popular
and represent an important motivation for sustaining training among leisure-time athletes.
However, there is a concern that prolonged, high-intensity exercise may increase the risk of
cardiovascular (CV) events. Following prolonged high-intensity exercise there is an increase
in levels of circulating markers of myocardial damage such as Troponin I (TnI). The precise
cause and clinical significance of this TnI increase is unknown.
- The primary objective of this study was to determine the relationship between
high-sensitive cardiac troponin I (hs-cTnI) levels and coronary artery disease and
cardiovascular outcomes in 1000 presumably healthy leisure sport athletes that
participated in a 91 km long, high intensity endurance cycling competition.
- The secondary objective was to assess the relationship between other CV risk factors,
fitness level and outcomes following high intensity endurance cycling competition in the
same population.
The NEEDED observational study was designed to be performed in two phases:
Phase 1 (NEEDED 2013) was a pilot study targeting 100 subjects to test the logistics and
identify the optimal blood sampling time points following the race. A total of 97 subjects
completed the pilot phase in June 2013.
Phase 2 (NEEDED 2014) aim to recruit another 1000 subjects from the participants of the race
in June 2014.
The study populations will be followed for cardiovascular events for up to 20 years following
the baseline blood samples.
The results from the two phases will be pooled for the main statistical analyses.
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