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LAX: New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01275963
Collaborator
(none)
400
Enrollment
1
Location
69
Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Oct 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

    1. left ventricular longitudinal systolic strain (LV-LSS) in all patients [2 years]

      left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging

    Secondary Outcome Measures

    1. mitral annular plane systolic excursion (MAPSE) in all patients [2 years]

      MAPSE is measured by M-Mode echocardiography

    2. mitral annular systolic velocity (MASV) in all patients [2 years]

      MASV is derived from tissue doppler

    3. diastolic left ventricular function in all patients [2 years]

      Diastolic function is assesed by mitral inflow, mitral annulus velocity, pulmonary vein flow and velocity of flow progression.

    4. pulmonary artery systolic pressure (PASP) in all patients [2 years]

      PASP is derived from Tricuspid valve regurgitation velocity

    5. left ventricular ejection fraction (LVEF) in all patients [2 years]

      EF is measured by modified Simpson's rule (biplane)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Derliz Mereles, Dr. Derliz Mereles, Heidelberg University
    ClinicalTrials.gov Identifier:
    NCT01275963
    Other Study ID Numbers:
    • S-401/2010
    First Posted:
    Jan 13, 2011
    Last Update Posted:
    Nov 8, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by Derliz Mereles, Dr. Derliz Mereles, Heidelberg University
    Echocardiography
    Strain imaging
    Ventricular Dysfunction
    Cardiomyopathy
    Longitudinal left ventricular function

    Study Results

    No Results Posted as of Nov 8, 2016