- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417586
Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke
New Ultrasound Instrument for Carotid Screening
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is the third leading cause of death, and the leading cause of long-term disability in the United States. At least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. Plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. Carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. Currently, the conventional duplex Doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. Study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. Previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. The purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. If the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke.
In this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. Patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. Screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. Individuals found to have carotid stenosis will be referred to undergo a conventional duplex Doppler ultrasound examination for a definitive diagnosis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- Princeton Surgical Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)
Exclusion Criteria:
- Any symptoms or indications of carotid stenosis or stroke
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Goldman, MD, Princeton Surgical Associates
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 468
- R44HL072534 (U.S. NIH Grant/Contract)
- R44HL072534-02A1 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Carotid Stenosis
-
Heinrich-Heine University, DuesseldorfRecruitingCarotid Artery Plaque | Carotid Artery Diseases | Carotid Artery Stenosis Asymptomatic | Carotid Artery StenosisGermany
-
Xuanwu Hospital, BeijingChanghai Hospital; Peking Union Medical College Hospital; The Second Hospital... and other collaboratorsRecruitingCarotid Artery Stenting | Carotid Endarterectomy | Best Medical Treatment | Carotid Artery Stenosis AsymptomaticChina
-
Xuanwu Hospital, BeijingRecruitingRadiation-induced Carotid Artery StenosisChina
-
Centre Hospitalier St AnneHôpitaux Universitaires Paris Ile-de-Franc OuestNot yet recruiting
-
Ochsner Health SystemWithdrawnTCD | Symptomatic Carotid Stenosis | Asymptomatic Carotid Stenosis | HITSUnited States
-
University of BolognaActive, not recruiting
-
W.L.Gore & AssociatesCompleted
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); Cedars-Sinai Medical Center and other collaboratorsRecruitingCarotid Atherosclerosis | Asymptomatic Carotid Artery Stenosis | Carotid Artery AtheromaUnited States
-
Aesculap AGEnrolling by invitationCarotid Artery Stenosis | Iliac Artery Stenosis | Femoral Artery StenosisGermany
-
Mayo ClinicRecruitingPatients With Any Degree of Carotid Artery Stenosis and Vulnerable Features in the Carotid Artery PlaqueUnited States
Clinical Trials on Specialized Doppler Ultrasound Instrument
-
University of British ColumbiaCompleted
-
ResQ Medical LtdNot yet recruitingPPH | Postpartum Hemorrhage \(PPH\) | Postpartum Hemorrhage \(Primary\)Kenya
-
Alydia HealthCompleted
-
The University of Texas Health Science Center,...University of Alabama at BirminghamCompleted
-
Ramsay Générale de Santémermoz hospitalRecruitingUpper Aero-intestinal Tract Cancer | Supraclavicular Flap | Anterior Thoracic Perforator ArteryFrance
-
Southeast University, ChinaQinghai UniversityRecruiting
-
Assiut UniversityNot yet recruitingUrinary Tract Injuries During Caesarean Section for Morbidly Adherent Placenta: Prospective and Retrospective StudyEgypt
-
Assiut UniversityUnknown
-
Central Hospital, Nancy, FranceUnknownCritically Ill | Central Venous Catheter Thrombosis | PARENTERAL NUTRITION | POST OPERATIVEFrance
-
Echosense Ltd.TerminatedSystemic Sclerosis | Pulmonary HypertensionIsrael