NCT02500745

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

September 2, 2014

Last Update Submit

July 14, 2015

Conditions

Thrombosis of Left Atrial Appendage

Outcome Measures

Primary Outcomes (1)

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

    Day 1

Study Arms (1)

Transesophageal echocardiography

Patients referred for transesophageal echocardiography for a clinical indication

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred for transesophageal echocardiography

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of cincinnati medical center

Cincinnati, Ohio, 45267, United States

Location

Study Officials

  • David Harris

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsayed Abo-salem

CONTACT

513-558-1032

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 2, 2014

First Posted

July 16, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations

US(1)