Berlin Beat of Running Study

November 7, 2016 updated by: Karl Georg Haeusler, Charite University, Berlin, Germany

Berlin Beat of Running Study - Frequency of Cardiac Arrhythmias & Cerebral Lesions in Marathon Runners

This prospective observational study will investigate the frequency of new onset atrial fibrillation (AF) and of further cardiac arrhythmias as well as of (clinically silent) cerebral lesions in endurance runners before, during and after the BMW-Berlin Marathon 2011.

Study Overview

Status

Completed

Conditions

Detailed Description

Up to 120 experienced marathon runners will participate in the "Berlin Beat of Running Study" and will wear a transportable electrocardiogram (ECG) recorder at least 24 hours before, during and 24 hours after the BMW-Berlin Marathon. All participants will undergo brain MRI examinations to detect cerebral lesions within days before and after the marathon race, respectively. Moreover, serial blood samples will be taken a few days before, immediately after as well as a few days after the BMW-Berlin Marathon.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Center for Stroke Research Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Experienced marathon runners

Description

Inclusion Criteria:

  • Age 35-65 years
  • at least 2 marathon runs within the last 5 years
  • weekly running of at least 40 km

Exclusion Criteria:

  • Known cardiac arrhythmia or prior stroke
  • contraindication for MRI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording
Time Frame: Up to 48 hours after the marathon race.
During ECG recording
Up to 48 hours after the marathon race.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.
Time Frame: 3 days
Up to 3 days after marathon.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Center for Stroke Research Berlin
Medical Institute BMW-Berlin Marathon, Berlin, Germany

Investigators

  • Principal Investigator: Karl Georg Haeusler, MD, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.
  • Study Chair: Matthias Endres, MD, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany
  • Study Chair: Wilhelm Haverkamp, MD, Departement of Cardiology, Campus Virchow, Charité - Universitätsmedizin Berlin, Germany
  • Study Chair: Matthias Kruell, MD, Medical Institute BMW-Berlin Marathon
  • Study Chair: Peter U Heuschmann, MD, Center for Stroke Research Berlin
  • Principal Investigator: Gerhard Jan Jungehuelsing, MD, Center for Stroke Research Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Berlin Beat
  • EA4/042/11 (Other Identifier: Ethics Committee Charité - Universitätsmedizin Berlin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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