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Completed

NCT Number: NCT02550340

Munich Study for Beer Related ECG Change Workup

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

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Key information

Conditions

Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum der Universitaet Muenchen, Department of Medicine I

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • informed conset signature

Exclusion criteria

  • Incapability of contracting according to German law (BGB §105, paragraph 2)
  • contraindications against ECG recording or alcohol breath test
  • denial of informed consent

Treatment and study plan

acute alcohol intake

Other

Smart phone based ECG recording

Primary outcomes

  1. Occurence of cardiac arrhythmias

    Time frame: 30 sec

Secondary outcomes

  1. Alcohol related changes in ECG intervals

    Time frame: 30 sec

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: Munich BREW

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2015
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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