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NCT00131001 Clinical Trial

CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Carotid Stenosis Clinical Trial

Official title:
Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00131001
Other study ID # 99.203
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 16, 2005
Last updated October 17, 2008
Start date April 2001

Study information
Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

Carotid artery stenosis > 50%

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• contrast-enhanced magnetic resonance angiography

Locations
Country Name City State
France Hôpital Louis Pradel Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis
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