Carotid Ultrasound in the Evaluation of Heart Failure | NCT00810550

Studies
Carotid Ultrasound in the Evaluation of Heart Failure

NCT00810550

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Apr 6, 2016Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease
Cardiomyopathy
Heart Failure

Interventions

Carotid ultrasound

Countries

Not provided

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

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 18, 2008Estimated

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

Apr 5, 2016

Last Update Posted Date

Apr 6, 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

Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.

Detailed Description

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LV systolic dysfunction	Other	Diagnostic Testing	Other: Carotid ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carotid ultrasound	Other	Measurement of intima-media thickness	LV systolic dysfunction

Measure	Description	Time Frame
Diagnostic accuracy for severe CAD		1 Day

Measure	Description	Time Frame
Diagnostic accuracy for significant CAD		1 Day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LVEF 40% or less

Exclusion Criteria:

Prior diagnosis of coronary or carotid obstructive atherosclerosis

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

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20569720	Derived	Reynolds HR, Steckman DA, Tunick PA, Kronzon I, Lobach I, Rosenzweig BP. Normal intima-media thickness on carotid ultrasound reliably excludes an ischemic cause of cardiomyopathy. Am Heart J. 2010 Jun;159(6):1059-66. doi: 10.1016/j.ahj.2010.03.026.

ID	Term
D003324	Coronary Artery Disease
D009202	Cardiomyopathies
D006333	Heart Failure

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases