New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function

Cardiovascular Pathology Clinical Trial

— LAX  

Official title:

New Echocardiographic Parameters for Assessment of Longitudinal Left Ventricular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275963
• Other study ID #: S-401/2010
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: November 5, 2016
• Start date: January 2011
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Pathology

Locations

Country	Name	City	State
Germany	University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular longitudinal systolic strain (LV-LSS) in all patients	left ventricular longitudinal systolic strain (LV-LSS) is measured in all patients by speckle tracking strain imaging	2 years	No
Secondary	mitral annular plane systolic excursion (MAPSE) in all patients	MAPSE is measured by M-Mode echocardiography	2 years	No
Secondary	mitral annular systolic velocity (MASV) in all patients	MASV is derived from tissue doppler	2 years	No
Secondary	diastolic left ventricular function in all patients	Diastolic function is assesed by mitral inflow, mitral annulus velocity, pulmonary vein flow and velocity of flow progression.	2 years	No
Secondary	pulmonary artery systolic pressure (PASP) in all patients	PASP is derived from Tricuspid valve regurgitation velocity	2 years	No
Secondary	left ventricular ejection fraction (LVEF) in all patients	EF is measured by modified Simpson's rule (biplane)	2 years	No