Clinical Trial

The North Sea Race Endurance Exercise Study

Study acronym: NEEDED
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2014-06-15; most recent amendment 2017-10-17.
Status change: Enrolling by Invitation → Active, Not Recruiting 2014-06-19
Trial Details
NCT Number NCT02166216
Lead Sponsor Helse Stavanger HF
Collaborators: Nordsjørittet, Abbott
Conditions Healthy
Enrollment 1,200 participants
Start Date 2013-06
Primary Completion 2034-06 (estimated)
Study Completion 2034-06 (estimated)
Updated on ClinicalTrials.gov 2017-10-19