Left Atrial Volume Index and Left Atrial Appendage Flow Velocities

Thrombosis of Left Atrial Appendage Clinical Trial

Official title:

Left Atrial Volume Index and Left Atrial Appendage Flow Velocities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02500745
• Other study ID #: LAA velocity & LA volume
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2014
• Last updated: July 14, 2015
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2015
• Source: University of Cincinnati
• Contact: Elsayed Abo-salem
• Phone: 513-558-1032
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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:

• 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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Thrombosis of Left Atrial Appendage

Locations

Country	Name	City	State
United States	University of cincinnati medical center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between left atrium volume index and Left atrial appendage flow velocity		Day 1	No