NCT00417586

Brief Summary

Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
984

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.3 years

First QC Date

December 28, 2006

Last Update Submit

December 9, 2013

Conditions

Carotid StenosisCerebrovascular Accident

Keywords

Stroke

Interventions

Specialized Doppler Ultrasound InstrumentDEVICE

Patients with a reading of 140 cm/sec or higher will be referred for further duplex screening

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care patients who fit inclusion criteria

You may qualify if:

  • At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)

You may not qualify if:

  • Any symptoms or indications of carotid stenosis or stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princeton Surgical Associates

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Carotid StenosisStroke

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kenneth Goldman, MD

    Princeton Surgical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

June 1, 2007

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

US(1)