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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Derliz Mereles, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01275963
First received: January 12, 2011
Last updated: August 25, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • left ventricular longitudinal systolic strain (LV-LSS) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    MAPSE is measured by M-Mode echocardiography

  • mitral annular systolic velocity (MASV) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    MASV is derived from tissue doppler

  • diastolic left ventricular function in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    PASP is derived from Tricuspid valve regurgitation velocity

  • left ventricular ejection fraction (LVEF) in all patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    EF is measured by modified Simpson's rule (biplane)


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275963

Contacts
Contact: Derliz Mereles, M.D. +49622156 ext 8852 derliz.mereles@med.uni-heidelberg.de
Contact: Matthias Aurich, M.D. +49622156 ext 38893 matthias.aurich@med.uni-heidelberg.de

Locations
Germany
University of Heidelberg Recruiting
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

Additional Information:
No publications provided

Responsible Party: Derliz Mereles, Dr. Derliz Mereles, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01275963     History of Changes
Other Study ID Numbers: S-401/2010
Study First Received: January 12, 2011
Last Updated: August 25, 2013
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 28, 2014