NCT02550340

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,029

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

September 13, 2015

Last Update Submit

April 25, 2016

Conditions

Arrhythmias, Cardiac

Keywords

ArrhythmiaAlcoholECG

Outcome Measures

Primary Outcomes (1)

  • Occurence of cardiac arrhythmias

    30 sec

Secondary Outcomes (1)

  • Alcohol related changes in ECG intervals

    30 sec

Study Arms (1)

Acute alcohol intake

Visitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria

Other: acute alcohol intake

Interventions

acute alcohol intakeOTHER

Smart phone based ECG recording

Acute alcohol intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants of the Munich Octoberfest and similar events

You may qualify if:

  • years of age and older
  • informed conset signature

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Universitaet Muenchen, Department of Medicine I

Munich, 81377, Germany

Location

Related Publications (2)

  • 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.

    PMID: 33738543DERIVED

  • Brunner 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.

    PMID: 28449090DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Stefan Brunner, MD

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

DE(1)