- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02657824
Rapid and Easy Evaluation of Cardiac Systolic Function by Means of Mitral Valve Movements in the Emergency Department
February 7, 2016 updated by: Neslihan Siliv, Bozyaka Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
113
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
an acutely dyspneic patients with receiving echocardigraphy by the chief physicians in the emergency department
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
measuring ejection fraction
ejection fraction in an acute dyspneic patients
|
measuring mitral valve and septal distance in acute dyspneic patients for estimating left ventricular ejection fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspneic patients were evaluated for their left ventricular ejection fraction by new methods with using transthoracic echocardiography.
Time Frame: up to 2 hours after admitting to the emergency department
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: neslihan siliv, ızmır bozyaka traınıng and research hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
December 22, 2015
First Submitted That Met QC Criteria
January 14, 2016
First Posted (ESTIMATE)
January 18, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2016
Last Update Submitted That Met QC Criteria
February 7, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06072015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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