Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis

This study has been terminated.
(Insufficient recruitment to complete study)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01236313
First received: November 4, 2010
Last updated: February 16, 2016
Last verified: February 2016
  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.

Condition Intervention
Coronary Disease
Cardiac Valve Disease
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 ]

Enrollment: 51
Study Start Date: July 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
TEE report
Cardiac surgery patients requiring TEE
Procedure: TEE report
Information will be collected during cardiac surgery.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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

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, M.D. Weill Medical College of Cornell University
  More Information

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: February 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plan to share IPD

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Heart Valve Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 26, 2016