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Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables (An Intraoperative Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874991
First Posted: April 3, 2009
Last Update Posted: July 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
The aim of this research is to apply cardiac tissue characterization in order to assess left ventricular function in cardiac surgical patients pre and post cardiopulmonary bypass. The procedures to be used include a retrospective review of transesophageal images obtained during conventional intraoperative transesophageal echocardiography (TEE) for cardiac surgery, as well as a secondary analysis with Tissue Doppler. The results will be compared with hemodynamic data obtained from a pulmonary artery catheter (PAC).

Condition
Cardiac Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cardiac Deformation: Correlation With Conventional Echocardiographic Hemodynamic Variables. An Intraoperative Study.

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

Primary Outcome Measures:
  • assess left ventricular function in cardiac patients pre and post cardiopulmonary bypass [ Time Frame: 1 ]

Enrollment: 198
Study Start Date: June 2008
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Patients included in this study are between the ages of 18 to 99 years of age, who presented to the operating room for cardiac surgery, and received both a pulmonary artery catheter and a routine intra-operative TEE. We will only be looking at patients whose TEE images were of good quality.

Subjects underwent cardiac surgery and received both a PAC and a routine TEE exam. We will review the data from the PAC, the images from the conventional TEE exam, and a secondary analysis with Tissue Doppler.

A potential benefit to society is a novel means for assessing left ventricular function. Our research will not benefit our subjects directly. There is no additional risk to our subjects beyond the insertion of the PAC and the TEE probe, which are routinely placed in our patients under-going cardiac surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cardiac surgery with general anesthesia.
Criteria

Inclusion Criteria:

  • Male or female patients >18 years of age Patients scheduled for cardiac surgery and will receive both a pulmonary artery catheter and a routine intra-operative TEE

Exclusion Criteria:

  • TEE images that are of poor quality
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874991


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nikolaos Skubas, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00874991     History of Changes
Other Study ID Numbers: 0709009426
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Keywords provided by Weill Medical College of Cornell University:
Cardiac deformation
Cardiopulmonary bypass
TEE
Cardiac Surgery
Left ventricular function
Pulmonary Artery catheter
Tissue Doppler
Left ventricular function in cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases