Specke Tracking Echocardiography And Filling Pressures
TEE
Feasibility of Speckle Tracking Echocardiography for Estimation of Left Ventricular Filling Pressures in Cardiac Surgery Patients: a Transoesophageal Study
1 other identifier
observational
30
1 country
1
Brief Summary
Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. The aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis. AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. 30 Patients scheduled for elective cardiac surgery will be included in the study group. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 20, 2017
October 1, 2017
3.4 years
July 20, 2016
October 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
global longitudinal peak systolic strain (GLPSS) acquired by transoesophageal echocardiography
postoperative offline measurement of strain
30min after Induction of anaesthesia
Study Arms (1)
Echocardiography
assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP
Interventions
assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP
Eligibility Criteria
all patients schedulded for elective cardiac surgery
You may qualify if:
- patients scheduled for elective cardiac surgery
You may not qualify if:
- non-sinus rhythm
- severe mitral regurgitation
- mitral stenosis
- prosthetic mitral valve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical university of vienna, General hospital of Vienna
Vienna, 1090, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrike Weber, M.D.
Medical University of Vienna
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 20, 2016
First Posted
August 4, 2016
Study Start
January 1, 2015
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
October 20, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share