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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00131001
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 17, 2005
Last Update Posted : October 20, 2008
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment
Carotid Stenosis Procedure: contrast-enhanced magnetic resonance angiography

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Study Start Date : April 2001

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Carotid artery stenosis > 50%

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131001


Locations
France
Hôpital Louis Pradel
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Philippe DOUEK, MD Hospices Civils de Lyon
More Information

ClinicalTrials.gov Identifier: NCT00131001     History of Changes
Other Study ID Numbers: 99.203
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: April 2007

Keywords provided by Hospices Civils de Lyon:
Carotid artery stenosis
cost effectiveness
magnetic resonance angiography
computed tomography angiography
digital subtraction angiography

Additional relevant MeSH terms:
Constriction, Pathologic
Carotid Stenosis
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases