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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02657824
Other study ID # 06072015
Secondary ID
Status Completed
Phase N/A
First received December 22, 2015
Last updated February 7, 2016
Start date August 2015
Est. completion date October 2015

Study information

Verified date January 2016
Source Bozyaka Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

A prospective observational study was conducted in an acutely dyspneic patients with receiving echocardiagraphy by the chief physicians. Measurements were performed before echocardiography lab by the physician who conducted the survey in the emergency department. In parasternal long axis view mitral valve E-Point Septal Separation (EPSS) M-Mod measurements and mitral valve anterior leaflet and septal distance (P-ALSS) B-Mod measurements and in apical four chamber view mitral valve anterior leaflet and septal distance (A-ALSS) B-Mod measurements and distance between mitral valve anterior and posterior leaflets (MVLS) B-Mod measurements were acquired as the minimum distance in diastole. LVEF of patients were measured by cardiologist. Correlation of the all values between LVEF and sensitivity, specificity, and likelihood probabilities were calculated.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date October 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- older than 18 years

- nontraumatic acute dyspneic patients

Exclusion Criteria:

- sigmoid septum

- septal hypertrophia

- mitral stenosis

- mitral valve prothesis

- aortic regurgitation

- regional wall motion defect

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bozyaka Training and Research Hospital

References & Publications (3)

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 — View Citation

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.1553-2712.201 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
See also
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