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Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System (Pro-MagIC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166903
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : March 13, 2020
Sponsor:
Collaborators:
Balgrist University Hospital
Deutsches Herzzentrum Muenchen
Information provided by (Responsible Party):
Johannes Scherr, Balgrist University Hospital

Brief Summary:
Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

Condition or disease
Participants of the Be-MaGIC-Study 2009

Detailed Description:

Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years.

For this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations.

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Study Type : Observational
Estimated Enrollment : 277 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Changes of right ventricular systolic function (RV-EF) [ Time Frame: 10 years ]
    Echocardiography


Secondary Outcome Measures :
  1. Changes in left ventricular ejection fraction (LV-EF) [ Time Frame: 10 years ]
    Echocardiography

  2. Changes in left ventricular diastolic function (E/e´) [ Time Frame: 10 years ]
    Echocardiography

  3. Change in cardiac markers (e.g. cardiac Troponin) [ Time Frame: 10 years ]
    Clinical chemistry (blood samples)

  4. Change in inflammation markers (e.g. C-reactive Protein) [ Time Frame: 10 years ]
    Clinical chemistry (blood samples)

  5. Change in microcirculation (e.g. arteriolar-to-venular ratio) [ Time Frame: 10 years ]
    Static Retinal Vessel Analyzer

  6. Change in macrocirculation (e.g. Intima media thickness) [ Time Frame: 10 years ]
    Carotid sonography

  7. Change of prevalence of cardiovascular diseases [ Time Frame: 10 years ]
    Questionnaire

  8. Association between changes of aforementioned parameters (see Topics 1-8) and potential underlying causes (e.g. sports history like number of ultraendurance competitions) in the examined cohort [ Time Frame: 10 years ]

Biospecimen Retention:   Samples Without DNA
blood sample: whole blood, serum, plasma


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants of the Be-MaGIC-Study (2009)
Criteria

Inclusion Criteria:

Declaration of consent Participants must have participated in the Be-MaGIC study in 2009

  • current age: 30 - 70 years
  • sex: male

Exclusion Criteria:

-


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): NCT04166903


Contacts
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Contact: Michael Schindler, MD +49 (0) 89 289 24441 Michael.Schindler@mri.tum.de
Contact: Julia Schoenfeld, MSc. +49 (0)89 289 24517 Julia.Schoenfeld2@mri.tum.de

Locations
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Germany
Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany Recruiting
Munich, Bavaria, Germany, 80992
Contact: Michael Schindler, MD       Michael.schindler@mri.tum.de   
Contact: Julia Schoenfeld, MSc.       Julia.schoenfeld2@mri.tum.de   
Sponsors and Collaborators
Technische Universität München
Balgrist University Hospital
Deutsches Herzzentrum Muenchen
Investigators
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Study Director: Michael Schindler, MD Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
Principal Investigator: Johannes Scherr, MD University Hospital Balgrist, University Zurich, Switzerland
Study Director: Martin Halle, MD Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johannes Scherr, Prof. Dr. med. Johannes Scherr, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT04166903    
Other Study ID Numbers: ProMagIC-Study
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johannes Scherr, Balgrist University Hospital:
Prolonged exercise, marathon, cardiovascular disease, long term