Myocardial Deformation Imaging After Acute Alcohol Excess

NCT ID: NCT02759445

Last Updated: 2016-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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Background: Chronic excessive alcohol consumption leads to progressive and chronic cardiac dysfunction. In general, patients consuming alcohol more than five years are at risk for the development of dilated cardiomyopathy. As only few data about immediate changes in left ventricular function after acute excessive alcohol ingestion are available, this study sought to close this gap.

Methods: 200 subjects (not used to alcohol, no cardiac disease) will be examined up to 12 hours after alcohol excess and after 4 weeks of complete alcohol abstinence. Echocardiography will performed at baseline and at follow-up regarding conventional parameter \[as left ventricular ejection fraction (LVEF), transmitral early (E) and late (A) Doppler flow velocities, E/A ratio, deceleration time of E (DT) and isovolumic relaxation time (IVRT)\] and myocardial deformation data \[as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain\].

Detailed Description

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Conditions

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Myocardial Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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routine treatment

No intervention, only observation and describing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subjects who are not used to alcohol
* subjets who had an excessive alcohol Ingestion up to 12 hours before echocardiography

Exclusion Criteria

* any heart disease
* subjects under 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Becker, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine I, University Hospital Aachen

Locations

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Department of Cardiology, RWTH Aachen University Hospital

Aachen, , Germany

Site Status

Countries

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Germany

Central Contacts

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Michael Becker, Prof.

Role: CONTACT

0049-241-8037137

Facility Contacts

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Michael Becker, Prof.

Role: primary

0049-241-8089301

Other Identifiers

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14-110

Identifier Type: OTHER

Identifier Source: secondary_id

C2-Strain

Identifier Type: -

Identifier Source: org_study_id

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