The North Sea Race Endurance Exercise Study (NEEDED)

Helse Stavanger HF

Status: Active, not recruiting

Conditions: Healthy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02166216

SUS2013ORST01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Healty subjects

Description:

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