NCT00874991

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

6.8 years

First QC Date

April 2, 2009

Last Update Submit

July 7, 2016

Conditions

Cardiac Disease

Keywords

Cardiac deformationCardiopulmonary bypassTEECardiac SurgeryLeft ventricular functionPulmonary Artery catheterTissue DopplerLeft ventricular function in cardiac surgery

Outcome Measures

Primary Outcomes (1)

  • assess left ventricular function in cardiac patients pre and post cardiopulmonary bypass

    1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac surgery with general anesthesia.

You may qualify if:

  • 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

You may not qualify if:

  • TEE images that are of poor quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Nikolaos Skubas, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

June 1, 2008

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations

US(1)