Overview

This trial is active, not recruiting.

Condition healthy
Sponsor Helse Stavanger HF
Collaborator Nordsjørittet
Start date June 2013
End date June 2034
Trial size 1200 participants
Trial identifier NCT02166216, SUS2013ORST01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Healthy subjects that participate in a high intensity, endurance bicycle race.

Primary Outcomes

Measure
The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
time frame: 30 days

Secondary Outcomes

Measure
The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
time frame: 1 year
The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
time frame: 5 years
The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
time frame: 20 years

Eligibility Criteria

Male or female participants at least 16 years old.

Inclusion Criteria: - participants in the "North sea race" - presumably healthy persons - signed informed consent - answered internet based questionnaire prior to the race Exclusion Criteria: - cardiac disease - hypertension - diabetes mellitus - use of primary cardiovascular medical prevention

Additional Information

Official title The North Sea Race Endurance Exercise Study
Principal investigator Stein Ørn, MD PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Helse Stavanger HF.