Aortic Wall and Left Ventricular Mechanics: Echocardiogra... | NCT01236313

Studies
Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis

NCT01236313

Sponsor

Weill Medical College of Cornell University

Status

Terminated

Last Update Posted

Feb 18, 2016Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Coronary Disease
Cardiac Valve Disease

Interventions

TEE report

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment to complete study

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Nov 4, 2010

First Submission Date that Met QC Criteria

Nov 4, 2010

First Posted Date

Nov 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEE report		Cardiac surgery patients requiring TEE	Procedure: TEE report

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TEE report	Procedure	Information will be collected during cardiac surgery.	TEE report

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the dimensions of the aorta and compare with blood pressure measurements		1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing bypass and/or valve surgery with general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolaos Skubas, M.D.	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided