Cardiac ArrhythmiaNCT01428778
Berlin Beat of Running Study
An observational study of Cardiac Arrhythmia and Brain Lesion, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia, Brain Lesion, Stroke
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Experienced marathon runners
Who may be able to join
- Age 35-65 years
- at least 2 marathon runs within the last 5 years
- weekly running of at least 40 km
Who cannot join
- Known cardiac arrhythmia or prior stroke
- contraindication for MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Berlin Beat of Running Study - Frequency of Cardiac Arrhythmias & Cerebral Lesions in Marathon Runners
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.
Read the 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.
- Conditions
- Cardiac Arrhythmia, Brain Lesion, Stroke
- Keywords
- Marathon running, Brain MRI, ECG recording, Blood tests
- Medical subject headings
- Arrhythmias, Cardiac, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording
During ECG recording
Measured: Up to 48 hours after the marathon race.
Secondary outcomes (1)
Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.
Up to 3 days after marathon.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Medical Institute BMW-Berlin Marathon, Berlin, Germany
- Responsible party
- Principal investigator, Karl Georg Haeusler, Charite University, Berlin, Germany
- Investigators
- Karl Georg Haeusler, MD, Principal investigator, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.Matthias Endres, MD, Study chair, Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, GermanyWilhelm Haverkamp, MD, Study chair, Departement of Cardiology, Campus Virchow, Charité - Universitätsmedizin Berlin, GermanyMatthias Kruell, MD, Study chair, Medical Institute BMW-Berlin MarathonPeter U Heuschmann, MD, Study chair, Center for Stroke Research BerlinGerhard Jan Jungehuelsing, MD, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428778
- Sponsor's protocol ID
- Berlin Beat
- Other IDs
- EA4/042/11
- Status last verified
- Nov 2016
- First submitted
- 31 Aug 2011
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28775185Haeusler 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.
PubMed 22938148
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berlin Beat of Running Study - Frequency of Cardiac Arrhythmias & Cerebral Lesions in Marathon Runners
- ClinicalTrials.gov ID
- NCT01428778
- Acronym / sponsor ID
- Berlin Beat
- Conditions
- Cardiac Arrhythmia, Brain Lesion, Stroke
- Keywords
- Marathon running, Brain MRI, ECG recording, Blood tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Medical Institute BMW-Berlin Marathon, Berlin, Germany
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experienced marathon runners
Key inclusion criteria (3 listed)
- Age 35-65 years
- at least 2 marathon runs within the last 5 years
- weekly running of at least 40 km
Key exclusion criteria (2 listed)
- Known cardiac arrhythmia or prior stroke
- contraindication for MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Rate of (clinically silent) cerebral lesions detected by 3 Tesla brain MRI.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 28775185Herm 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.
- Derived from this study: PubMed 22938148Haeusler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Georg Haeusler, MD principal investigator
Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.
Matthias Endres, MD study chair
Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany
Wilhelm Haverkamp, MD study chair
Departement of Cardiology, Campus Virchow, Charité - Universitätsmedizin Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia and Brain Lesion, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cardiac arrhythmias in marathon runners detected by mobile ECG-recording (time frame: Up to 48 hours after the marathon race.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428778, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.