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

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ClinicalTrials.gov Identifier: NCT00810550
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Cardiomyopathy Heart Failure Other: Carotid ultrasound Not Applicable

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  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Carotid Ultrasound in the Evaluation of Heart Failure
Study Start Date : October 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Diagnostic accuracy for severe CAD [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. Diagnostic accuracy for significant CAD [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LVEF 40% or less

Exclusion Criteria:

  • Prior diagnosis of coronary or carotid obstructive atherosclerosis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harmony R. Reynolds, MD, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00810550     History of Changes
Other Study ID Numbers: NYCC CUE-HF
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

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