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Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial (MAGIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845286
First Posted: February 18, 2009
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität München
  Purpose
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.

Condition Intervention
Heart Failure Sudden Cardiac Death Behavioral: Munich Marathon

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of Myocardial Function and Vascular Adaptation in Association With Genotype in Marathon Runners

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • E/A ratio [ Time Frame: pre-, post-, one day follow-up ]

Secondary Outcome Measures:
  • LV twist [ Time Frame: pre-, post-, one day follow-up ]

Enrollment: 162
Study Start Date: September 2008
Study Completion Date: August 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Munich Marathon
    42,195 km marathon run
    Other Name: MAGIC
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men aged 30-60 years

Exclusion Criteria:

  • manifested heart disease
  • insulin dependent diabetes mellitus
  • multi drug therapy
  • GFR<60ml/min.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845286


Locations
Germany
Department of Prevention and Sports medicine
Munich, Bavaria, Germany, 80809
Sponsors and Collaborators
Technische Universität München
  More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00845286     History of Changes
Other Study ID Numbers: 1807/07-II
First Submitted: September 19, 2008
First Posted: February 18, 2009
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Technische Universität München:
exercise, myocardial dysfunction, endothelial dysfunction,
polymorphism

Additional relevant MeSH terms:
Heart Failure
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden