The North Sea Race Endurance Exercise Study

NCT02166216 | Active Not Recruiting

• 1 other identifier: SUS2013ORST01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Prolonged high intensity exercise; Healthy subjects; Cardiovascular risk markers; Troponin; Leisure sports athletes; Cycling; CT coronary angiography; Outcomes

Outcome Measures

Primary Outcomes (1)

• The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition

  Blood will be drawn at 24 hours prior to, and at 3 and 24 hours following a 91 km long mountain bike race. The level of high sensitive TnI will be analyzed at all time-points. All study participants will be followed-up for 30 days, and all events will be recorded. Additionally, based on data from the NEEDED 2013 pilot study all participants with an increase in high sensitive cTni \> 200 ng/l within 24 hours following the cycling competition will be assessed by CT coronary angiography within the first week following the race to determine the presence of significant coronary artery disease in order to detect subclinical coronary artery disease.

  30 days

Secondary Outcomes (3)

• The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition

  1 year

• The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition

  5 years

• The relationship between high sensitive cTni and coronary artery disease and CV events following a high intensity mountain bike competition

  20 years

Study Arms (1)

Healty subjects

Healthy subjects that participate in a high intensity, endurance bicycle race.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• participants in the "North sea race"
• presumably healthy persons
• signed informed consent
• answered internet based questionnaire prior to the race

You may not qualify if:

• cardiac disease
• hypertension
• diabetes mellitus
• use of primary cardiovascular medical prevention

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Nordsjørittet: collaborator
• Abbott: collaborator

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Related Publications (6)

• 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.

  PMID: 39158569 DERIVED

• 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.

  PMID: 34459237 DERIVED

• 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.

  PMID: 34183020 DERIVED

• 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.

  PMID: 32930023 DERIVED

• 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.

  PMID: 32065043 DERIVED

• 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.

  PMID: 30842026 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum EDTA Whole blood

Study Officials

• Stein Ørn, MD PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 18, 2014
• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2034
• Study Completion (Estimated): June 1, 2034
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

NO (1)