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

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ClinicalTrials.gov Identifier: NCT04166903
Recruitment Status : Unknown
Verified March 2020 by Johannes Scherr, Balgrist University Hospital.
Recruitment status was:  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

Tracking Information
First Submitted Date November 13, 2019
First Posted Date November 18, 2019
Last Update Posted Date March 13, 2020
Actual Study Start Date November 15, 2019
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2019)
Changes of right ventricular systolic function (RV-EF) [ Time Frame: 10 years ]
Echocardiography
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System
Official Title Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood sample: whole blood, serum, plasma
Sampling Method Non-Probability Sample
Study Population Participants of the Be-MaGIC-Study (2009)
Condition Participants of the Be-MaGIC-Study 2009
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 14, 2019)
277
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: Male
Ages 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04166903
Other Study ID Numbers ProMagIC-Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Johannes Scherr, Balgrist University Hospital
Original Responsible Party Same as current
Current Study Sponsor Technical University of Munich
Original Study Sponsor Same as current
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
PRS Account Technical University of Munich
Verification Date March 2020