NCT01428778

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

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

August 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

August 31, 2011

Last Update Submit

November 7, 2016

Conditions

Keywords

Marathon runningBrain MRIECG recordingBlood tests

Outcome Measures

Primary Outcomes (1)

  • Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording

    During ECG recording

    Up to 48 hours after the marathon race.

Secondary Outcomes (1)

  • Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.

    3 days

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Experienced marathon runners

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Stroke Research Berlin

Berlin, Germany

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples

MeSH Terms

Conditions

Arrhythmias, CardiacStroke

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Karl Georg Haeusler, MD

    Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR
  • Gerhard Jan Jungehuelsing, MD

    Center for Stroke Research Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 5, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations