Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis

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:
NCT01236313
First received: November 4, 2010
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. Measurements of the aorta are obtained by an ultrasound-based imaging technique called transesophageal echocardiography (TEE), which is routinely performed during cardiac surgery. TEE is an instrument used to monitor the heart and is standard of practice at Weill Cornell Medical College.


Condition Intervention
Coronary Artery Bypass Graft or Valve Surgery
Procedure: TEE report

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Measure the dimensions of the aorta and compare with blood pressure measurements [ Time Frame: 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: July 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TEE report Procedure: TEE report
Information will be collected during 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 bypass and/or valve surgery with general anesthesia

Criteria

Inclusion Criteria:

  • elective CABG, valvular procedure

Exclusion Criteria:

  • non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.
  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: NCT01236313

Contacts
Contact: Nikolaos Skubas, M.D. 212-746-2755 njs2002@med.cornell.edu
Contact: Michele Steinkamp, RN 212-746-2953 mls9004@med.cornell.edu

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

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01236313     History of Changes
Other Study ID Numbers: 1005011039
Study First Received: November 4, 2010
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
TEE
Cardiac Surgery
Pulse Pressure

ClinicalTrials.gov processed this record on August 28, 2014