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

NCT ID: NCT00131001

Last Updated: 2008-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Stenosis

Keywords

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Carotid artery stenosis cost effectiveness magnetic resonance angiography computed tomography angiography digital subtraction angiography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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contrast-enhanced magnetic resonance angiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Carotid artery stenosis \> 50%
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Principal Investigators

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Philippe DOUEK, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Louis Pradel

Bron, , France

Site Status

Countries

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France

Other Identifiers

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99.203

Identifier Type: -

Identifier Source: org_study_id