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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00874991
First received: April 2, 2009
Last updated: June 13, 2013
Last verified: June 2013
  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
Left Ventricular Function

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: June 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874991

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: michele Steinkamp, RN    212-746-2953    mls9004@med.cornell.edu   
Principal Investigator: Nikolaos Skubas, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Nikolaos Skubas, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00874991     History of Changes
Other Study ID Numbers: 0709009426
Study First Received: April 2, 2009
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014