ClinicalTrials.gg
Status unknownNCT02500745Updated Jul 16, 2015

Left Atrial Volume Index and Left Atrial Appendage Flow Velocities

An observational study in Thrombosis of Left Atrial Appendage, sponsored by University of Cincinnati. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-16.

Sponsored by University of Cincinnati · Observational

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 80 Years
Sex
All
01

Study summary

After obtaining a consent, bed side cardiac ultrasonography will be performed for cases undergoing transesophageal echocardiography to evaluate the correlation between left atrium volume and left atrial appendage flow velocity which can predict the thrombosis risk.

Read the detailed description

Informed consent will be obtained prior to any research related procedures Prior to performing the transesophageal echocardiography, 4 and a 2-chamber transthoracic images will be obtained to perform standard left atrial volumetric assessment as well as speckle tracking interrogation. Both these procedures will be performed offline. The transesophageal echocardiography will be performed using available equipment with a 5- to 7-megaHertz multiplane transducer and according to standard of care. All images will be acquired per American Society of Echocardiography guidelines and will be recorded for further analysis. The left atrial appendage will be best visualized in the 60, 90 and 110 degree imaging planes and left atrial appendage contraction velocity will be recorded by placing a pulsed wave Doppler sample volume inside the proximal third of the left atrial appendage at each angle. In addition, images will be recorded using a 3-beat cycle capture to later perform offline velocity vector imaging analysis for left atrial appendage speckle tracking analysis. The transthoracic echocardiography will be performed just before the transesophageal echocardiography examination using a 2- to 4-megaHertz transducer and according to standard practice guidelines. The following echocardiographic variables will be prospectively measured and calculated: left ventricle ejection fraction using Simpson method, left atrial volume will be measured using biplane method and left atrium volume index is calculated based on body surface area. Tissue Doppler images of mitral valve annulus will be measured and Pulsed wave Doppler of mitral inflow velocity.

Study does not include follow up. Study duration is up to 24 months

02

Conditions studied

  • Thrombosis of Left Atrial Appendage
03

In context

Lead sponsor

University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients referred for transesophageal echocardiography

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Study will include all patients 18-80 years of age and referred for transesophageal evaluation of left atrium or left atrium appendage for appropriate clinical indications, at the University of Cincinnati University Medical Center and VA Medical Center.

Exclusion criteria

Exclusion Criteria:

  • Patients with either moderate to sever mitral valve disease or previous prosthetic mitral replacement.
  • Patients with acute heart failure
  • History of previous left atrium appendage surgical intervention.
  • Pregnant women
05

Study design

Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Transesophageal echocardiography

    Patients referred for transesophageal echocardiography for a clinical indication

06

What researchers measure

Primary outcomes

  1. Correlation between left atrium volume index and Left atrial appendage flow velocity

    Time frame: Day 1

07

Study locations

1 site
  • University of cincinnati medical center
    Cincinnati, Ohio 45267, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02500745
Responsible party
Elsayed Abo-Salem (M.D., University of Cincinnati) — Principal investigator
First posted
Jul 16, 2015
Start date
Jul 2015
Primary completion
Jul 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Jul 16, 2015

Study contacts

Elsayed Abo-salem
Contact
513-558-1032
David Harris
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion