- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759445
Myocardial Deformation Imaging After Acute Alcohol Excess (C2)
Detection of Early Changes in Left Ventricular Function by Myocardial Deformation Imaging After Acute Excessive Alcohol Ingestion
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].
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Aachen, Germany, 52074
- Department of Cardiology, RWTH Aachen University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial Dysfunction by echocardiographic parameters
Time Frame: At 4 weeks follow-up
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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
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At 4 weeks follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in echocardiographic parameters
Time Frame: from baseline to follow up at 4 weeks
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These echocardiographic parameters will be determined at baseline and at 4 weeks follow up and the changes (assessed by percentage differences) will be given
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from baseline to follow up at 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Becker, Prof., Department of Internal Medicine I, University Hospital Aachen
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- C2-Strain
- 14-110 (CTC-A)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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