Myocardial Deformation Imaging After Acute Alcohol Excess

• Conditions: Myocardial Dysfunction

• Registration Number: NCT02759445
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-11-24
• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-29
• Last Update Submitted: 2016-04-29
• Study First Posted: 2016-05-03
• Last Update Posted: 2016-05-03
• Primary Completion: 2016-09
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial Dysfunction by echocardiographic parameters	At 4 weeks follow-up	Conventional echocardiographic parameters as left ventricular ejection fraction (measured in %) and volumes (measured in ml) and myocardial Deformation parameters as global and layer specific radial, longitudinal and circumferential strain (all measured in %) will be determined

Secondary Outcome Measures

Name	Time	Method
Change from baseline in echocardiographic parameters	from baseline to follow up at 4 weeks	These echocardiographic parameters will be determined at baseline and at 4 weeks follow up and the changes (assessed by percentage differences) will be given

Trial Locations

Locations (1)

Department of Cardiology, RWTH Aachen University Hospital; 🇩🇪 Aachen, Germany