NCT00877565

Brief Summary

Systolic function is a substantial determinant of overall hemodynamics and organ function. Therefore assessment of left ventricular systolic function (LVF) has been of central interest in Echocardiography. Ejection fraction (EF) measurement has been the gold standard echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load dependent measure. Global longitudinal peak systolic strain average is a new parameter derived from speckle tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an equivalent to EF measurement, but maybe less load dependend. The aim of the study is to investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in cardiac and non-cardiac cases).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at 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

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
Last Updated

April 8, 2009

Status Verified

April 1, 2009

First QC Date

April 7, 2009

Last Update Submit

April 7, 2009

Conditions

Keywords

LVFLeft ventricular systolic function

Outcome Measures

Primary Outcomes (1)

  • multivariate regression-analysis

    1, 5 years

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing cardiac and non-cardiac surgery

You may qualify if:

  • Adult patients in the age from 19-90 years
  • Cardiac and non-cardiac surgery, where intubation is indicated
  • Surgical procedures with a minimum duration of 30 min
  • Elective cardiac surgery on patients scheduled for correction of:
  • coronary artery disease with and without previous myocardial infarction
  • dilated cardiomyopathy; HOCM
  • disorders of the atrial or ventricular septum
  • disorders of the aortic root or the aorta
  • left and right heart valvular disease including stenotic and/or regurgitant valvular diseases.

You may not qualify if:

  • No patient´s consent
  • Contraindications for TEE (esophageal-, gastric disorders, haematologic disorders with increased bleeding incidence; ENT-surgery, surgery of the esophageus or stomach)
  • Contraindications for positioning (e.g. clinical signs of acute lung edema/acute failing left or right heart, acute coronary syndrome, myocardial infarction in recent history = within 2 weeks prior to operation date)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Heinz D Tschernich, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

February 1, 2009

Last Updated

April 8, 2009

Record last verified: 2009-04

Locations