We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function (LAX)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01275963
First Posted: January 13, 2011
Last Update Posted: November 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Derliz Mereles, Heidelberg University
  Purpose

Assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. Qualitative eyeball method and biplane modified Simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. Due to the complexity of the myocardial architecture, global left ventricular function also has longitudinal and torsional components.

The aim of this study is to evaluate new echocardiographic parameters for longitudinal left ventricular function. A special focus is set on strain imaging by speckle tracking, which is a relatively new technique. Patients with different cardiac pathologies (e. g. dilated cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared to healthy individuals.


Condition
Cardiovascular Pathology

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function

Further study details as provided by Derliz Mereles, Heidelberg University:

Primary Outcome Measures:
  • left ventricular longitudinal systolic strain (LV-LSS) in all patients [ Time Frame: 2 years ]
    left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging


Secondary Outcome Measures:
  • mitral annular plane systolic excursion (MAPSE) in all patients [ Time Frame: 2 years ]
    MAPSE is measured by M-Mode echocardiography

  • mitral annular systolic velocity (MASV) in all patients [ Time Frame: 2 years ]
    MASV is derived from tissue doppler

  • diastolic left ventricular function in all patients [ Time Frame: 2 years ]
    Diastolic function is assesed by mitral inflow, mitral annulus velocity, pulmonary vein flow and velocity of flow progression.

  • pulmonary artery systolic pressure (PASP) in all patients [ Time Frame: 2 years ]
    PASP is derived from Tricuspid valve regurgitation velocity

  • left ventricular ejection fraction (LVEF) in all patients [ Time Frame: 2 years ]
    EF is measured by modified Simpson's rule (biplane)


Enrollment: 400
Study Start Date: January 2011
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Healthy individuals without structural heart disease
CAD
Patients with coronary artery disease
DCM
Participants with dilated cardiomyopathy
HNCM
Patients with hypertrophic non-obstructive cardiomyopathy
HOCM
Patients with hypertrophic obstructive cardiomyopathy
RCM
Patients with restrictive cardiomyopathy
Amyloidosis
Patients with cardiac manifestation of amyloidosis
HFPEF
Patients with heart failure with preserved ejection fraction (diastolic heart failure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals and patients with various cardiac pathologies, who undergo routine echocardiography at our department
Criteria

Inclusion Criteria:

  • persons of 18 years and older who receive a transthoracic echocardiography at our department
  • written consent

Exclusion Criteria:

  • permanent pacemaker rhythm
  • moderate/severe valvular heart disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275963


Locations
Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Matthias Aurich, M.D. Heidelberg University
Principal Investigator: Derliz Mereles, M.D. Heidelberg University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Derliz Mereles, Dr. Derliz Mereles, Heidelberg University
ClinicalTrials.gov Identifier: NCT01275963     History of Changes
Other Study ID Numbers: S-401/2010
First Submitted: January 12, 2011
First Posted: January 13, 2011
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Derliz Mereles, Heidelberg University:
Echocardiography
Strain imaging
Ventricular Dysfunction
Cardiomyopathy
Longitudinal left ventricular function