Carotid Ultrasound in the Evaluation of Heart Failure (CUE-HF)

April 5, 2016 updated by: Harmony R. Reynolds, NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • LVEF 40% or less

Exclusion Criteria:

  • Prior diagnosis of coronary or carotid obstructive atherosclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LV systolic dysfunction
Diagnostic Testing
Other: Carotid ultrasound
Measurement of intima-media thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy for severe CAD
Time Frame: 1 Day
1 Day

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic accuracy for significant CAD
Time Frame: 1 Day
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYCC CUE-HF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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