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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harmony R. Reynolds, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00810550
First received: December 17, 2008
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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 Intervention
Coronary Artery Disease
Cardiomyopathy
Heart Failure
Other: Carotid ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Carotid Ultrasound in the Evaluation of Heart Failure

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Diagnostic accuracy for severe CAD [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic accuracy for significant CAD [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LV systolic dysfunction
Diagnostic Testing
Other: Carotid ultrasound
Measurement of intima-media thickness

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.
  Eligibility

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

Inclusion Criteria:

  • LVEF 40% or less

Exclusion Criteria:

  • Prior diagnosis of coronary or carotid obstructive atherosclerosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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 
Study First Received: December 17, 2008
Last Updated: April 5, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 25, 2016