Arrhythmias, CardiacMunich BREWNCT02550340
Munich Study for Beer Related ECG Change Workup
An observational study of Arrhythmias, Cardiac, run by LMU Klinikum at 1 site in Germany.
Trial summary
The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- acute alcohol intake
- How many people
- 3,029 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Apr 2016
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants of the Munich Octoberfest and similar events
Who may be able to join
- 18 years of age and older
- informed conset signature
Who cannot join
- Incapability of contracting according to German law (BGB §105, paragraph 2)
- contraindications against ECG recording or alcohol breath test
- denial of informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Universitaet Muenchen, Department of Medicine I
Munich, 81377
About this study
The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.
Read the detailed description
Both regular and acute excessive alcohol intake may deteriorate health. Possible sequelae include cardiac arrhythmias. For acute alcohol intake in particular it is insufficiently understood to what extent cardiac arrhythmias and other ECG changes occur, if the occurence depends on alcohol levels, and if there is a cut off value for occurence. Munich BREW aims to help clarifying these questions.
Participants of Munich BREW are identified and invited as visitors of the Munich Octoberfest and similar events. Participants need to be 18 years of age and over and need to declare theri will to participate. Following enrollment, participants will answer astudy questionnaire and will subsequently undergo recording of a 30 sec smart phone based ECG. Ultimately, the alcohol level is determined using a breath alcohol analyzer.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- acute alcohol intake
- Keywords
- Arrhythmia, Alcohol, ECG
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute alcohol intakeOther
Smart phone based ECG recording
| Study group | Role | What they receive |
|---|---|---|
| Acute alcohol intake | Visitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria Receives: Other: acute alcohol intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of cardiac arrhythmias
Measured: 30 sec
Secondary outcomes (1)
Alcohol related changes in ECG intervals
Measured: 30 sec
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
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 Arrhythmias, CardiacStudies of the same condition, open and under way.
- 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
- 3,029 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Stefan Brunner, LMU Klinikum
- Investigators
- Stefan Brunner, MD, Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550340
- Sponsor's protocol ID
- Muc-M002-15
- Acronym
- Munich BREW
- Status last verified
- Apr 2016
- First submitted
- 13 Sep 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brunner S, Drobesch C, Herbel R, Sinner MF. Effects of acute alcohol consumption on cardiac excitation, conduction, and repolarization: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Clin Res Cardiol. 2021 Jun;110(6):916-918. doi: 10.1007/s00392-021-01839-6. Epub 2021 Mar 18. No abstract available.
PubMed 33738543Brunner S, Herbel R, Drobesch C, Peters A, Massberg S, Kaab S, Sinner MF. Alcohol consumption, sinus tachycardia, and cardiac arrhythmias at the Munich Octoberfest: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Eur Heart J. 2017 Jul 14;38(27):2100-2106. doi: 10.1093/eurheartj/ehx156.
PubMed 28449090
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Munich Study for Beer Related ECG Change Workup
- ClinicalTrials.gov ID
- NCT02550340
- Acronym / sponsor ID
- Munich BREW / Muc-M002-15
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Arrhythmia, Alcohol, ECG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,029 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Sep 2015 (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.
The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.
Detailed description
Both regular and acute excessive alcohol intake may deteriorate health. Possible sequelae include cardiac arrhythmias. For acute alcohol intake in particular it is insufficiently understood to what extent cardiac arrhythmias and other ECG changes occur, if the occurence depends on alcohol levels, and if there is a cut off value for occurence. Munich BREW aims to help clarifying these questions.
Participants of Munich BREW are identified and invited as visitors of the Munich Octoberfest and similar events. Participants need to be 18 years of age and over and need to declare theri will to participate. Following enrollment, participants will answer astudy questionnaire and will subsequently undergo recording of a 30 sec smart phone based ECG. Ultimately, the alcohol level is determined using a breath alcohol analyzer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute alcohol intake | – | Other: acute alcohol intakeVisitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the Munich Octoberfest and similar events
Key inclusion criteria (2 listed)
- 18 years of age and older
- informed conset signature
Key exclusion criteria (3 listed)
- Incapability of contracting according to German law (BGB §105, paragraph 2)
- contraindications against ECG recording or alcohol breath test
- denial of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute alcohol intakeSmart phone based ECG recording | Other | Acute alcohol intake |
Primary outcome
Occurence of cardiac arrhythmias
Time frame: 30 sec
1 secondary outcome
Alcohol related changes in ECG intervals
Time frame: 30 sec
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 26 Apr 2016.
- Derived from this study: PubMed 33738543Brunner S, Drobesch C, Herbel R, Sinner MF. Effects of acute alcohol consumption on cardiac excitation, conduction, and repolarization: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Clin Res Cardiol. 2021 Jun;110(6):916-918. doi: 10.1007/s00392-021-01839-6. Epub 2021 Mar 18. No abstract available.
- Derived from this study: PubMed 28449090Brunner S, Herbel R, Drobesch C, Peters A, Massberg S, Kaab S, Sinner MF. Alcohol consumption, sinus tachycardia, and cardiac arrhythmias at the Munich Octoberfest: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Eur Heart J. 2017 Jul 14;38(27):2100-2106. doi: 10.1093/eurheartj/ehx156.
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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.
Stefan Brunner, MD principal investigator
LMU Klinikum
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 Arrhythmias, Cardiac, run by LMU Klinikum 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 2 inclusion and 3 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 26 Apr 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?
Occurence of cardiac arrhythmias (time frame: 30 sec). 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 NCT02550340, 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 26 Apr 2016.