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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00845286
Other study ID # 1807/07-II
Secondary ID
Status Completed
Phase N/A
First received September 19, 2008
Last updated March 16, 2016
Start date September 2008
Est. completion date August 2014

Study information

Verified date March 2016
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Technical University of Munich
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with genotype/polymorphisms. We aim to investigate the effects of extreme endurance exercise on the cardiovascular system. Furthermore, the role of the inflammatory response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.


Description:

Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of augmentation index (AIx), arteriolar-venular ratio (AVR) and, for the first time, 2D and 3D echocardiographic measurements such as TDI-imaging and speckle tracking. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor. Additionally, cardiovascular markers are measured. All variations are analysed on the basis of genotype characteristics/polymorphisms.


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date August 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria:

- men aged 30-60 years

Exclusion Criteria:

- manifested heart disease

- insulin dependent diabetes mellitus

- multi drug therapy

- GFR<60ml/min.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Munich Marathon
42,195 km marathon run

Locations

Country Name City State
Germany Department of Prevention and Sports medicine Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary E/A ratio pre-, post-, one day follow-up Yes
Secondary LV twist pre-, post-, one day follow-up Yes
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