Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1200 participants
OBSERVATIONAL
2013-06-30
2034-06-30
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healty subjects
Healthy subjects that participate in a high intensity, endurance bicycle race.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* presumably healthy persons
* signed informed consent
* answered internet based questionnaire prior to the race
Exclusion Criteria
* hypertension
* diabetes mellitus
* use of primary cardiovascular medical prevention
16 Years
ALL
Yes
Sponsors
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Nordsjørittet
UNKNOWN
Abbott
INDUSTRY
Helse Stavanger HF
OTHER_GOV
Responsible Party
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Principal Investigators
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Stein Ørn, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Helse Stavanger HF
Locations
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Stavanger University Hospital
Stavanger, , Norway
Countries
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References
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Erevik CB, Kleiven O, Froysa V, Bjorkavoll-Bergseth M, Chivulescu M, Klaeboe LG, Dejgaard L, Auestad B, Skadberg O, Melberg T, Urheim S, Haugaa K, Edvardsen T, Orn S. Exercise-Induced Cardiac Troponin I Elevation Is Associated With Regional Alterations in Left Ventricular Strain in High-Troponin Responders. J Am Heart Assoc. 2024 Aug 20;13(16):e034382. doi: 10.1161/JAHA.124.034382. Epub 2024 Aug 19.
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.
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.
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.
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.
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.
Other Identifiers
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SUS2013ORST01
Identifier Type: -
Identifier Source: org_study_id