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

Participants of the Be-MaGIC-Study 2009 Clinical Trial

— Pro-MagIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166903
• Other study ID #: ProMagIC-Study
• Status: Recruiting
• Start date: November 15, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Technische Universität München
• Contact: Michael Schindler, MD
• Phone: +49 (0) 89 289 24441
• Email: Michael.Schindler[@]mri.tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 277
• Est. completion date: December 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Participants of the Be-MaGIC-Study 2009

Locations

Country	Name	City	State
Germany	Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany	Munich	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität München	Balgrist University Hospital, Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

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