Clinical trial NCT01428778: Berlin Beat of Running Study
Official title: Berlin Beat of Running Study - Frequency of Cardiac Arrhythmias & Cerebral Lesions in Marathon Runners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Brain Lesion
Stroke
Keywords: Marathon running
Brain MRI
ECG recording
Blood tests
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
name: Medical Institute BMW-Berlin Marathon, Berlin, Germany
First posted: 2011-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Experienced marathon runners

Brief summary: 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.

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 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.

Primary outcomes:
measure: Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording
timeFrame: Up to 48 hours after the marathon race.
Secondary outcomes:
measure: Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.
timeFrame: 3 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Stroke Research Berlin
Study officials:
affiliation: Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.
name: Karl Georg Haeusler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany
name: Matthias Endres, MD
role: STUDY_CHAIR
affiliation: Departement of Cardiology, Campus Virchow, Charité - Universitätsmedizin Berlin, Germany
name: Wilhelm Haverkamp, MD
role: STUDY_CHAIR
affiliation: Medical Institute BMW-Berlin Marathon
name: Matthias Kruell, MD
role: STUDY_CHAIR
affiliation: Center for Stroke Research Berlin
name: Peter U Heuschmann, MD
role: STUDY_CHAIR
affiliation: Center for Stroke Research Berlin
name: Gerhard Jan Jungehuelsing, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herm J, Topper A, Wutzler A, Kunze C, Krull M, Brechtel L, Lock J, Fiebach JB, Heuschmann PU, Haverkamp W, Endres M, Jungehulsing GJ, Haeusler KG. Frequency of exercise-induced ST-T-segment deviations and cardiac arrhythmias in recreational endurance athletes during a marathon race: results of the prospective observational Berlin Beat of Running study. BMJ Open. 2017 Aug 3;7(8):e015798. doi: 10.1136/bmjopen-2016-015798.
citation: Haeusler KG, Herm J, Kunze C, Krull M, Brechtel L, Lock J, Hohenhaus M, Heuschmann PU, Fiebach JB, Haverkamp W, Endres M, Jungehulsing GJ. Rate of cardiac arrhythmias and silent brain lesions in experienced marathon runners: rationale, design and baseline data of the Berlin Beat of Running study. BMC Cardiovasc Disord. 2012 Aug 31;12:69. doi: 10.1186/1471-2261-12-69.