NCT00131001

Brief Summary

PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis. MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS), contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct costs of each imaging method were calculated in 2 university medical centers. Eight hypothetical models were studied with DUS considered as the first-line imaging method and either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
Last Updated

October 20, 2008

Status Verified

April 1, 2007

First QC Date

August 16, 2005

Last Update Submit

October 17, 2008

Conditions

Carotid Stenosis

Keywords

Carotid artery stenosiscost effectivenessmagnetic resonance angiographycomputed tomography angiographydigital subtraction angiography

Outcome Measures

Primary Outcomes (1)

  • To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis

Interventions

contrast-enhanced magnetic resonance angiographyPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Carotid artery stenosis \> 50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Bron, 69677, France

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philippe DOUEK, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

April 1, 2001

Last Updated

October 20, 2008

Record last verified: 2007-04

Locations

FR(1)