Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System

Overview

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.

Full Title of Study: “Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2020

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.

Clinical Trial Outcome Measures

Primary Measures

  • Changes of right ventricular systolic function (RV-EF)
    • Time Frame: 10 years
    • Echocardiography

Secondary Measures

  • Changes in left ventricular ejection fraction (LV-EF)
    • Time Frame: 10 years
    • Echocardiography
  • Changes in left ventricular diastolic function (E/e´)
    • Time Frame: 10 years
    • Echocardiography
  • Change in cardiac markers (e.g. cardiac Troponin)
    • Time Frame: 10 years
    • Clinical chemistry (blood samples)
  • Change in inflammation markers (e.g. C-reactive Protein)
    • Time Frame: 10 years
    • Clinical chemistry (blood samples)
  • Change in microcirculation (e.g. arteriolar-to-venular ratio)
    • Time Frame: 10 years
    • Static Retinal Vessel Analyzer
  • Change in macrocirculation (e.g. Intima media thickness)
    • Time Frame: 10 years
    • Carotid sonography
  • Change of prevalence of cardiovascular diseases
    • Time Frame: 10 years
    • Questionnaire
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 30 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Technische Universität München
  • Collaborator
    • Balgrist University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Johannes Scherr, Prof. Dr. med. Johannes Scherr – Balgrist University Hospital
  • Overall Official(s)
    • Michael Schindler, MD, Study Director, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
    • Johannes Scherr, MD, Principal Investigator, University Hospital Balgrist, University Zurich, Switzerland
    • Martin Halle, MD, Study Director, Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
  • Overall Contact(s)
    • Michael Schindler, MD, +49 (0) 89 289 24441, Michael.Schindler@mri.tum.de

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