Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02166216

The North Sea Race Endurance Exercise 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, NO-4011, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 30 days

    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.

Secondary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 5 years

    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.

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

    Time frame: 20 years

    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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Abbott
  • Nordsjørittet

Registry information

Acronym: NEEDED

Important dates

Study start
2013
Primary completion
2034
Study completion
2034
First posted
Jun 18, 2014
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.