Berlin Beat of Running Study

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428778
• Other study ID #: Berlin Beat
• Secondary ID: EA4/042/11
• Status: Completed
• Phase: N/A
• First received: August 31, 2011
• Last updated: November 7, 2016
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Brain Lesion
• Cardiac Arrhythmia
• Stroke

Locations

Country	Name	City	State
Germany	Center for Stroke Research Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Center for Stroke Research Berlin, Medical Institute BMW-Berlin Marathon, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording	During ECG recording	Up to 48 hours after the marathon race.	No
Secondary	Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.	Up to 3 days after marathon.	3 days	No

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