Berlin Beat of Running Study

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01428778
First received: August 31, 2011
Last updated: August 6, 2013
Last verified: August 2013
  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 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. ] [ Designated as safety issue: No ]
    During ECG recording


Secondary Outcome Measures:
  • Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Charite University, Berlin, Germany

Additional 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
Study First Received: August 31, 2011
Last Updated: August 6, 2013
Health Authority: Germany: Ministry of Health

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

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Stroke
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014