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Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

This study is currently recruiting participants.

Verified November 2012 by Weill Medical College of Cornell University

Sponsor:

Information provided by (Responsible Party):

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT01734174

First received: November 20, 2012

Last updated: NA

Last verified: November 2012

History: No changes posted

Purpose

Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. The purpose of the study is to compare these two methods of echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely performed simultaneously. The study will also compare the echocardiography data to a third technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.

Condition	Intervention
3D Transesophageal and Transthoracic Echocardiogram	Procedure: transesophageal echocardiography (TEE) Procedure: thermodilution Procedure: transthoracic echocardiography (TTE)

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

General heart function (Left ventricular volume and ejection fraction) [ Time Frame: During cardiac surgery ] [ Designated as safety issue: No ]
Left ventricular volume will be assessed by 3-dimensional transesophageal echocardiography (3D TEE) and compared to data from 3-dimensional transthoracic echocardiography (3D TTE). 3D measurements will be compared to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, this assessment will be compared to a third method of quantification of cardiac function via a pulmonary artery catheter.

Estimated Enrollment:	150
Study Start Date:	September 2012
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
cardiac patients Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.	Procedure: transesophageal echocardiography (TEE) Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. Procedure: thermodilution A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other. Procedure: transthoracic echocardiography (TTE) Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.

Groups/Cohorts

Assigned Interventions

cardiac patients

Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.

Procedure: transesophageal echocardiography (TEE)

Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.

Procedure: thermodilution

A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other.

Procedure: transthoracic echocardiography (TTE)

Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.

Criteria

Inclusion Criteria:

Elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.
18 years or older

Exclusion criteria for thermodilution assessment are as follows:

Moderate to severe tricuspid regurgitation
Contraindications to pulmonary artery catheter placement based on the American Society of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization.

Exclusion criteria for performance of TEE:

Contraindications to the performance of TEE based on the Journal of the American Society of Echocardiologists' 2011 recommendations and the American Society of Anesthesiologist Guidelines for Performance of Perioperative Transesophageal Echocardiography.
Any degree of mitral regurgitation or aortic insufficiency above trace.

Exclusion criteria for performance of TTE, both 3D and 2D:

Qualified echocardiographer absent or unavailable.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734174

Contacts

Contact: Gila Hoffman, BS

212-746-9419

gih2004@med.cornell.edu

Locations

United States, New York
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10065
Contact: Gila Hoffman, BS 212-746-9419 gih2004@med.cornell.edu
Principal Investigator: Meghann M Fitzgerald, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Meghann Fitzgerald, MD

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT01734174 History of Changes
Other Study ID Numbers:	1207012636
Study First Received:	November 20, 2012
Last Updated:	November 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

transesophageal and transthoracic echocardiogram
thermodilution
left ventricular volume
ejection volume

ClinicalTrials.gov processed this record on May 16, 2013

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