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

Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 277

Contacts and Locations

• Study Contact: Name: Michael Schindler, MD; Phone Number: +49 (0) 89 289 24441; Email: Michael.Schindler@mri.tum.de
• Study Contact Backup: Name: Julia Schoenfeld, MSc.; Phone Number: +49 (0)89 289 24517; Email: Julia.Schoenfeld2@mri.tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80992
      • Recruiting
      • Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany
      • Contact: Michael Schindler, MD; Email: Michael.schindler@mri.tum.de
      • Contact: Julia Schoenfeld, MSc.; Email: Julia.schoenfeld2@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Participants of the Be-MaGIC-Study (2009)

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of right ventricular systolic function (RV-EF)	Echocardiography	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Balgrist University Hospital; Deutsches Herzzentrum Muenchen
• Investigators: 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 and helpful links

General Publications

• Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 11, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Prolonged exercise, marathon, cardiovascular disease, long term
• Other Study ID Numbers: ProMagIC-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No