Myocardial Deformation Imaging After Acute Alcohol Excess

NCT02759445 | Unknown DMC

• 2 other identifiers: C2-Strain14-110
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 \[as layer specific global circumferential (endo GCS, mid GCS, epi GCS) and longitudinal (endo GLS, mid GLS, epi GLS) strain\].

Conditions

Myocardial Dysfunction

Keywords

alcohol induced cardiomyopathy; myocardial deformation imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from baseline in echocardiographic parameters

  from baseline to follow up at 4 weeks

Interventions

routine treatment OTHER

No intervention, only observation and describing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects who are not used to alcohol and have no heart disease will be asked for an echocardipgraphy (at baseline and at 4 weeks follow-up) in case of excessive alcohol Ingestion up to 12 hours before determination

You may qualify if:

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

You may not qualify if:

• any heart disease
• subjects under 18 years

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Cardiology, RWTH Aachen University Hospital

Aachen, 52074, Germany

Location

Study Officials

• Michael Becker, Prof.

  Department of Internal Medicine I, University Hospital Aachen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Becker, Prof.

CONTACT

0049-241-8037137; mibecker@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: May 3, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-04

Locations

DE (1)