Munich Study for Beer Related ECG Change Workup (Munich BREW)

April 25, 2016 updated by: PD Dr. Stefan Brunner, LMU Klinikum
The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

3029

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 81377
        • Klinikum der Universitaet Muenchen, Department of Medicine I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants of the Munich Octoberfest and similar events

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute alcohol intake
Visitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria
Other: acute alcohol intake
Smart phone based ECG recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of cardiac arrhythmias
Time Frame: 30 sec
30 sec

Secondary Outcome Measures

Outcome Measure
Time Frame
Alcohol related changes in ECG intervals
Time Frame: 30 sec
30 sec

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Investigators

  • Principal Investigator: Stefan Brunner, MD, LMU Klinikum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 13, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Muc-M002-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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