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HealthyNEEDEDNCT02166216

The North Sea Race Endurance Exercise Study

An observational study of Healthy, run by Helse Stavanger HF at 1 site in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
1,200 participants
Where
1 siteNorway
Study dates
Jun 2013to Jun 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Healthy volunteers participating in the bicycle race "Northsea race" 2013 (pilot) and 2014 (main study), males and females.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Stavanger University Hospital

    Stavanger, NO-4011

Other trials in Norway

About this study

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.
Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02166216
Study groupRoleWhat they receive
Healty subjectsHealthy subjects that participate in a high intensity, endurance bicycle race.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (3)

  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 timepoints.All study participants will be followed-up for 30 days, and all CV 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.

    Measured: 1 year

  2. 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 timepoints.All study participants will be followed-up for 30 days, and all CV 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.

    Measured: 5 years

  3. 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 CV 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.

    Measured: 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2034 (estimated)
  4. Study completionJun 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02166216
Sponsor's protocol ID
SUS2013ORST01
Acronym
NEEDED
Status last verified
Oct 2017
First submitted
11 Jun 2014
Last updated
19 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39158569

  • 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.

    PubMed 34459237

  • 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.

    PubMed 34183020

  • 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.

    PubMed 32930023

  • 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.

    PubMed 32065043

  • 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.

    PubMed 30842026

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Helse Stavanger HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02166216, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.

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