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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Technische Universität München
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00845286
First received: September 19, 2008
Last updated: December 10, 2012
Last verified: December 2012
  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: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LV twist [ Time Frame: pre-, post-, one day follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 125
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: October 2008 (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

Ages Eligible for Study:   30 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845286

Contacts
Contact: Hanssen Henner, MD 0049-89-289244 ext 31 hanssen@sport.med.tum.de
Contact: Scherr Johannes, MD 0049-89-289244 ext 31 scherr@sport.med.tum.de

Locations
Germany
Department of Prevention and Sports medicine Recruiting
Munich, Bavaria, Germany, 80809
Contact: Hanssen Henner, MD    0049-89-289244 ext 31    hanssen@sport.med.tum.de   
Contact: Scherr Johannes, MD    0049-89-289-244 ext 31    scherr@sport.med.tum.de   
Principal Investigator: Hanssen Henner, MD         
Sub-Investigator: Scherr Johannes, MD         
Sponsors and Collaborators
Technische Universität München
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT00845286     History of Changes
Other Study ID Numbers: 1807/07-II
Study First Received: September 19, 2008
Last Updated: December 10, 2012
Health Authority: Germany: Technical University of Munich

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

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

ClinicalTrials.gov processed this record on September 18, 2014