Munich Study for Beer Related ECG Change Workup | NCT02550340

Studies
Munich Study for Beer Related ECG Change Workup

NCT02550340

Sponsor

LMU Klinikum

Status

Completed

Last Update Posted

Apr 26, 2016Estimated

Enrollment

3,029Estimated

Phase

Not provided

Conditions

Arrhythmias, Cardiac

Interventions

acute alcohol intake

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Sep 13, 2015

First Submission Date that Met QC Criteria

Sep 13, 2015

First Posted Date

Sep 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2016

Last Update Posted Date

Apr 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,029Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute alcohol intake		Visitors of the Munich Octoberfest or similar events who fulfil in- and exclusion criteria	Other: acute alcohol intake

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acute alcohol intake	Other	Smart phone based ECG recording	Acute alcohol intake

Measure	Description	Time Frame
Occurence of cardiac arrhythmias		30 sec

Measure	Description	Time Frame
Alcohol related changes in ECG intervals		30 sec

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants of the Munich Octoberfest and similar events

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Brunner, MD	LMU Klinikum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Universitaet Muenchen, Department of Medicine I		Munich		81377	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33738543	Derived	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.
28449090

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals