Back to resultsCARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Primary Purpose
Carotid Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
contrast-enhanced magnetic resonance angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Carotid Stenosis focused on measuring Carotid artery stenosis, cost effectiveness, magnetic resonance angiography, computed tomography angiography, digital subtraction angiography
Eligibility Criteria
Inclusion Criteria: Carotid artery stenosis > 50%
Sites / Locations
- Hôpital Louis Pradel
Outcomes
Primary Outcome Measures
To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00131001
First Posted
August 16, 2005
Last Updated
October 17, 2008
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT00131001
Brief Title
CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Official Title
Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Carotid artery stenosis, cost effectiveness, magnetic resonance angiography, computed tomography angiography, digital subtraction angiography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
contrast-enhanced magnetic resonance angiography
Primary Outcome Measure Information:
Title
To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Carotid artery stenosis > 50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe DOUEK, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Learn more about this trial
CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
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