The North Sea Race Endurance Exercise Study

Healthy Clinical Trial

— NEEDED  

Official title:

The North Sea Race Endurance Exercise Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02166216
• Other study ID #: SUS2013ORST01
• Status: Active, not recruiting
• Phase: N/A
• First received: June 11, 2014
• Last updated: October 17, 2017
• Start date: June 2013
• Est. completion date: June 2034

Study information

• Verified date: October 2017
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 2034
• Est. primary completion date: June 2034
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Helse Stavanger HF	Abbott, Nordsjørittet

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	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.	5 years
Secondary	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.	20 years