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NCT02550340 Clinical Trial

Munich Study for Beer Related ECG Change Workup

Arrhythmias, Cardiac Clinical Trial

— Munich BREW  

Official title:
Munich Study for Beer Related ECG Change Workup

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02550340
Other study ID # Muc-M002-15
Secondary ID
Status Completed
Phase N/A
First received September 13, 2015
Last updated April 25, 2016
Start date September 2015
Est. completion date April 2016

Study information
Verified date April 2016
Source Klinikum der Universitaet Muenchen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3029
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age and older

- informed conset signature

Exclusion Criteria:

- Incapability of contracting according to German law (BGB ยง105, paragraph 2)

- contraindications against ECG recording or alcohol breath test

- denial of informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• acute alcohol intake
Smart phone based ECG recording

Locations
Country Name City State
Germany Klinikum der Universitaet Muenchen, Department of Medicine I Munich

Sponsors (1)
Lead Sponsor Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurence of cardiac arrhythmias 30 sec No
Secondary Alcohol related changes in ECG intervals 30 sec No
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