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Berlin Beat of Running Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01428778
First Posted: September 5, 2011
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Center for Stroke Research Berlin
Medical Institute BMW-Berlin Marathon, Berlin, Germany
Information provided by (Responsible Party):
Karl Georg Haeusler, Charite University, Berlin, Germany
  Purpose
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.

Condition
Cardiac Arrhythmia Brain Lesion Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Berlin Beat of Running Study - Frequency of Cardiac Arrhythmias & Cerebral Lesions in Marathon Runners

Resource links provided by NLM:


Further study details as provided by Karl Georg Haeusler, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI. [ Time Frame: 3 days ]
    Up to 3 days after marathon.


Biospecimen Retention:   Samples Without DNA
Whole blood samples

Enrollment: 110
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Experienced marathon runners
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428778


Locations
Germany
Center for Stroke Research Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Georg Haeusler, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01428778     History of Changes
Other Study ID Numbers: Berlin Beat
EA4/042/11 ( Other Identifier: Ethics Committee Charité - Universitätsmedizin Berlin )
First Submitted: August 31, 2011
First Posted: September 5, 2011
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Karl Georg Haeusler, Charite University, Berlin, Germany:
Marathon running
Brain MRI
ECG recording
Blood tests

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes