Heart; Disease, Mitral(Valve)NCT02657824
Rapid and Easy Evaluation of Cardiac Systolic Function by Means of Mitral Valve Movements in the Emergency Department
An observational study of Heart; Disease, Mitral(Valve), run by Bozyaka Training and Research Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Disease, Mitral(Valve)
- What is being tested?
- dyspneic patients
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Oct 2015
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: an acutely dyspneic patients with receiving echocardigraphy by the chief physicians in the emergency department
Who may be able to join
- older than 18 years
- nontraumatic acute dyspneic patients
Who cannot join
- sigmoid septum
- septal hypertrophia
- mitral stenosis
- mitral valve prothesis
- aortic regurgitation
- regional wall motion defect
About this study
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.
Read the 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.
- Conditions
- Heart; Disease, Mitral(Valve)
- Being tested
- dyspneic patients
- Keywords
- Ejection fraction, mitral valve, e-point septal separation
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyspneic patientsOther
measuring mitral valve and septal distance in acute dyspneic patients for estimating left ventricular ejection fraction
| Study group | Role | What they receive |
|---|---|---|
| measuring ejection fraction | ejection fraction in an acute dyspneic patients Receives: Other: dyspneic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 hours after admitting to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart; Disease, Mitral(Valve)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Siliv, Bozyaka Training and Research Hospital
- Investigators
- neslihan siliv, Principal investigator, ızmır bozyaka traınıng and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657824
- Sponsor's protocol ID
- 06072015
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 22044429Weekes 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.
PubMed 23197541McKaigney 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.
PubMed 24630604
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid and Easy Evaluation of Cardiac Systolic Function by Means of Mitral Valve Movements in the Emergency Department
- ClinicalTrials.gov ID
- NCT02657824
- Acronym / sponsor ID
- 06072015
- Conditions
- Heart; Disease, Mitral(Valve)
- Keywords
- Ejection fraction, mitral valve, e-point septal separation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measuring ejection fraction | – | Other: dyspneic patientsejection fraction in an acute dyspneic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- an acutely dyspneic patients with receiving echocardigraphy by the chief physicians in the emergency department
Key inclusion criteria (2 listed)
- older than 18 years
- nontraumatic acute dyspneic patients
Key exclusion criteria (6 listed)
- sigmoid septum
- septal hypertrophia
- mitral stenosis
- mitral valve prothesis
- aortic regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dyspneic patientsmeasuring mitral valve and septal distance in acute dyspneic patients for estimating left ventricular ejection fraction | Other | measuring ejection fraction |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Results publication: PubMed 22044429Secko 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.
- Results publication: PubMed 23197541Weekes 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.
- Results publication: PubMed 24630604McKaigney 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
neslihan siliv principal investigator
ızmır bozyaka traınıng and research hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Heart; Disease, Mitral(Valve), run by Bozyaka Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657824, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.