NCT04166903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 17, 2025

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

November 13, 2019

Last Update Submit

September 11, 2025

Conditions

Keywords

Prolonged exercise, marathon, cardiovascular disease, long term

Outcome Measures

Primary Outcomes (1)

  • Changes of right ventricular systolic function (RV-EF)

    Echocardiography

    10 years

Secondary Outcomes (8)

  • Changes in left ventricular ejection fraction (LV-EF)

    10 years

  • Changes in left ventricular diastolic function (E/e´)

    10 years

  • Change in cardiac markers (e.g. cardiac Troponin)

    10 years

  • Change in inflammation markers (e.g. C-reactive Protein)

    10 years

  • Change in microcirculation (e.g. arteriolar-to-venular ratio)

    10 years

  • +3 more secondary outcomes

Eligibility Criteria

Age30 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants of the Be-MaGIC-Study (2009)

You may qualify if:

  • Declaration of consent Participants must have participated in the Be-MaGIC study in 2009
  • current age: 30 - 70 years
  • sex: male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany

Munich, Bavaria, 80992, Germany

Location

Related Publications (2)

  • Matsushima M, Bryan GT. Early induction of mouse urinary bladder ornithine decarboxylase activity by rodent vesical carcinogens. Cancer Res. 1980 Jun;40(6):1897-901.

    PMID: 7371022BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample: whole blood, serum, plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Michael Schindler, MD

    Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany

    STUDY DIRECTOR
  • Johannes Scherr, MD

    University Hospital Balgrist, University Zurich, Switzerland

    PRINCIPAL INVESTIGATOR
  • Martin Halle, MD

    Department of Prevention, Rehabilitation and Sports Medicine, Munich, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Johannes Scherr

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 18, 2019

Study Start

November 15, 2019

Primary Completion

October 5, 2020

Study Completion

June 30, 2021

Last Updated

September 17, 2025

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations