NCT00810550

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

3.2 years

First QC Date

December 17, 2008

Last Update Submit

April 5, 2016

Conditions

Coronary Artery DiseaseCardiomyopathyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy for severe CAD

    1 Day

Secondary Outcomes (1)

  • Diagnostic accuracy for significant CAD

    1 Day

Study Arms (1)

LV systolic dysfunction

OTHER

Diagnostic Testing

Other: Carotid ultrasound

Interventions

Carotid ultrasoundOTHER

Measurement of intima-media thickness

LV systolic dysfunction

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF 40% or less

You may not qualify if:

  • Prior diagnosis of coronary or carotid obstructive atherosclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20569720DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCardiomyopathiesHeart Failure

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

October 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 6, 2016

Record last verified: 2016-04