NCT02854865

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

July 20, 2016

Last Update Submit

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

Other: echocardiography

Interventions

assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP

Echocardiography

Eligibility Criteria

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

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

RECRUITING

Study Officials

  • Ulrike Weber, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

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

Locations