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

This study is ongoing, but not recruiting participants.

Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00131001
  Purpose

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.

RESULTS: DUS alone has the best cost-effectiveness ratio (1109 Euros for one avoided stroke) but the number of avoided strokes is significantly lower in comparison with other strategies including 2 or 3 imaging methods. A combination of DUS and CTA is the best strategy with 2 techniques (1450 Euros for one avoided stroke) compared with DUS-DSA (3635 Euros for one avoided stroke) or DUS-CEMRA (1914 Euros for one avoided stroke). DSA is not justified, neither for effectiveness nor for costs.

CONCLUSION: Considering that a combination of methods is better than only one modality, the best cost-effectiveness strategy for the assessment of symptomatic carotid stenosis is the combination of DUS and CTA. CEMRA, performed as the third line technique when DUS and CTA are discordant, allows for one more avoided stroke for 2000 patients.


Condition Intervention
Carotid Stenosis
Procedure: contrast-enhanced magnetic resonance angiography

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:   Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Further study details as provided by Hospices Civils de Lyon:

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

Estimated Enrollment:   300
Study Start Date:   April 2001

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Carotid artery stenosis > 50%

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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


Study ID Numbers:   99.203
First Received:   August 16, 2005
Last Updated:   April 26, 2007
ClinicalTrials.gov Identifier:   NCT00131001
Health Authority:   France: Ministry of Health

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

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Carotid Stenosis
Vascular Diseases
Central Nervous System Diseases
Constriction, Pathologic
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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