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

Primary Purpose

Heart Failure, Sudden Cardiac Death

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Munich Marathon
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring exercise, myocardial dysfunction, endothelial dysfunction,, polymorphism

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • men aged 30-60 years

Exclusion Criteria:

  • manifested heart disease
  • insulin dependent diabetes mellitus
  • multi drug therapy
  • GFR<60ml/min.

Sites / Locations

  • Department of Prevention and Sports medicine

Outcomes

Primary Outcome Measures

E/A ratio

Secondary Outcome Measures

LV twist

Full Information

First Posted
September 19, 2008
Last Updated
March 16, 2016
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00845286
Brief Title
Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial
Acronym
MAGIC
Official Title
Investigation of Myocardial Function and Vascular Adaptation in Association With Genotype in Marathon Runners
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sudden Cardiac Death
Keywords
exercise, myocardial dysfunction, endothelial dysfunction,, polymorphism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Munich Marathon
Other Intervention Name(s)
MAGIC
Intervention Description
42,195 km marathon run
Primary Outcome Measure Information:
Title
E/A ratio
Time Frame
pre-, post-, one day follow-up
Secondary Outcome Measure Information:
Title
LV twist
Time Frame
pre-, post-, one day follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men aged 30-60 years Exclusion Criteria: manifested heart disease insulin dependent diabetes mellitus multi drug therapy GFR<60ml/min.
Facility Information:
Facility Name
Department of Prevention and Sports medicine
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80809
Country
Germany

12. IPD Sharing Statement

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

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