NCT02657824

Brief Summary

Left ventricular ejection fraction (LVEF) is a parameter that should be evaluated rapidly to the patients, admitted to the emergency department with shortness of breath. The investigators aimed to investigate correlation between LVEF and 4 different mitral valve movements which alternate to the classical LVEF assessing methods and evaluate these methods can be used or not in the emergency department.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

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

August 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

December 22, 2015

Last Update Submit

February 7, 2016

Conditions

Keywords

Ejection fractionmitral valvee-point septal separation

Outcome Measures

Primary Outcomes (1)

  • Dyspneic patients were evaluated for their left ventricular ejection fraction by new methods with using transthoracic echocardiography.

    New methods are described: First measurement is distance between mitral valve anterior leaflet and septum in early diastole in the parasternal long axis view m-mode in millimeter.second measurement is distance between mitral valve anterior leaflet and septum in early diastole in the parasternal long axis view b-mode in millimeter. third is the distance between mitral valve anterior leaflet and septum in the apical four chamber view b-mode in millimeter. forth is the distance between mitral valve anterior and posterior leaflet in apical four chamber b-mode in millimeter.

    up to 2 hours after admitting to the emergency department

Study Arms (1)

measuring ejection fraction

ejection fraction in an acute dyspneic patients

Other: dyspneic patients

Interventions

measuring mitral valve and septal distance in acute dyspneic patients for estimating left ventricular ejection fraction

measuring ejection fraction

Eligibility Criteria

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

an acutely dyspneic patients with receiving echocardigraphy by the chief physicians in the emergency department

You may qualify if:

  • older than 18 years
  • nontraumatic acute dyspneic patients

You may not qualify if:

  • sigmoid septum
  • septal hypertrophia
  • mitral stenosis
  • mitral valve prothesis
  • aortic regurgitation
  • regional wall motion defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Secko MA, Lazar JM, Salciccioli LA, Stone MB. Can junior emergency physicians use E-point septal separation to accurately estimate left ventricular function in acutely dyspneic patients? Acad Emerg Med. 2011 Nov;18(11):1223-6. doi: 10.1111/j.1553-2712.2011.01196.x. Epub 2011 Nov 1.

  • Weekes AJ, Reddy A, Lewis MR, Norton HJ. E-point septal separation compared to fractional shortening measurements of systolic function in emergency department patients: prospective randomized study. J Ultrasound Med. 2012 Dec;31(12):1891-7. doi: 10.7863/jum.2012.31.12.1891.

  • McKaigney CJ, Krantz MJ, La Rocque CL, Hurst ND, Buchanan MS, Kendall JL. E-point septal separation: a bedside tool for emergency physician assessment of left ventricular ejection fraction. Am J Emerg Med. 2014 Jun;32(6):493-7. doi: 10.1016/j.ajem.2014.01.045. Epub 2014 Feb 3.

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • neslihan siliv

    ızmır bozyaka traınıng and research hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 18, 2016

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 9, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share