NCT01275963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

5.8 years

First QC Date

January 12, 2011

Last Update Submit

November 5, 2016

Conditions

Cardiovascular Pathology

Keywords

EchocardiographyStrain imagingVentricular DysfunctionCardiomyopathyLongitudinal left ventricular function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • mitral annular plane systolic excursion (MAPSE) in all patients

    2 years

  • mitral annular systolic velocity (MASV) in all patients

    2 years

  • diastolic left ventricular function in all patients

    2 years

  • pulmonary artery systolic pressure (PASP) in all patients

    2 years

  • left ventricular ejection fraction (LVEF) in all patients

    2 years

Study Arms (8)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals and patients with various cardiac pathologies, who undergo routine echocardiography at our department

You may qualify if:

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

You may not qualify if:

  • permanent pacemaker rhythm
  • moderate/severe valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

  • Aurich M, Keller M, Greiner S, Steen H, Aus dem Siepen F, Riffel J, Katus HA, Buss SJ, Mereles D. Left ventricular mechanics assessed by two-dimensional echocardiography and cardiac magnetic resonance imaging: comparison of high-resolution speckle tracking and feature tracking. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1370-1378. doi: 10.1093/ehjci/jew042. Epub 2016 Mar 24.

    PMID: 27013249DERIVED

MeSH Terms

Conditions

Ventricular DysfunctionCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Matthias Aurich, M.D.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

  • Derliz Mereles, M.D.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Derliz Mereles

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

DE(1)