Clinical trial NCT02166216: The North Sea Race Endurance Exercise Study
Official title: The North Sea Race Endurance Exercise Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Keywords: Prolonged high intensity exercise
Healthy subjects
Cardiovascular risk markers
Troponin
Leisure sports athletes
Cycling
CT coronary angiography
Outcomes
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Nordsjørittet
name: Abbott
First posted: 2014-06-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers participating in the bicycle race "Northsea race" 2013 (pilot) and 2014 (main study), males and females.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
timeFrame: 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
timeFrame: 1 year
measure: The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
timeFrame: 5 years
measure: The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition
timeFrame: 20 years
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Stein Ørn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorkavoll-Bergseth M, Erevik CB, Kleiven O, Eijsvogels TMH, Skadberg O, Froysa V, Wiktorski T, Auestad B, Edvardsen T, Aakre KM, Orn S. Determinants of Interindividual Variation in Exercise-Induced Cardiac Troponin I Levels. J Am Heart Assoc. 2021 Sep 7;10(17):e021710. doi: 10.1161/JAHA.121.021710. Epub 2021 Aug 28.
citation: Hansen MW, Orn S, Erevik CB, Bjorkavoll-Bergseth MF, Skadberg O, Melberg TH, Aakre KM, Kleiven O. Regular consumption of cod liver oil is associated with reduced basal and exercise-induced C-reactive protein levels; a prospective observational trial : A NEEDED (The North Sea Race Endurance Exercise Study) 2014 sub-study. J Int Soc Sports Nutr. 2021 Jun 28;18(1):51. doi: 10.1186/s12970-021-00437-1.
citation: Skranes JB, Kleiven O, Aakre KM, Skadberg O, Melberg TH, Omland T, Orn S. High-Sensitivity Cardiac Troponin I and T Response Following Strenuous Activity is Attenuated by Smokeless Tobacco: NEEDED (North Sea Race Endurance Exercise Study) 2014. J Am Heart Assoc. 2020 Oct 20;9(19):e017363. doi: 10.1161/JAHA.120.017363. Epub 2020 Sep 15.
citation: Bjorkavoll-Bergseth M, Kleiven O, Auestad B, Eftestol T, Oskal K, Nygard M, Skadberg O, Aakre KM, Melberg T, Gjesdal K, Orn S. Duration of Elevated Heart Rate Is an Important Predictor of Exercise-Induced Troponin Elevation. J Am Heart Assoc. 2020 Feb 18;9(4):e014408. doi: 10.1161/JAHA.119.014408. Epub 2020 Feb 17.
citation: Kleiven O, Omland T, Skadberg O, Melberg TH, Bjorkavoll-Bergseth MF, Auestad B, Bergseth R, Greve OJ, Aakre KM, Orn S. Race duration and blood pressure are major predictors of exercise-induced cardiac troponin elevation. Int J Cardiol. 2019 May 15;283:1-8. doi: 10.1016/j.ijcard.2019.02.044. Epub 2019 Feb 23.