Myocardial Deformation Imaging After Acute Alcohol Excess

Myocardial Dysfunction Clinical Trial

— C2  

Official title:

Detection of Early Changes in Left Ventricular Function by Myocardial Deformation Imaging After Acute Excessive Alcohol Ingestion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02759445
• Other study ID #: C2-Strain
• Secondary ID: 14-110
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2015
• Last updated: April 29, 2016
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: April 2016
• Source: RWTH Aachen University
• Contact: Michael Becker, Prof.
• Phone: 0049-241-8037137
• Email: mibecker[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocardial Dysfunction

Intervention

Other:
• routine treatment
No intervention, only observation and describing

Locations

Country	Name	City	State
Germany	Department of Cardiology, RWTH Aachen University Hospital	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Dysfunction by echocardiographic parameters	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	At 4 weeks follow-up	No
Secondary	Change from baseline in echocardiographic parameters	These echocardiographic parameters will be determined at baseline and at 4 weeks follow up and the changes (assessed by percentage differences) will be given	from baseline to follow up at 4 weeks	No