Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Information provided by:
Hospices Civils de Lyon Identifier:
First received: August 16, 2005
Last updated: October 17, 2008
Last verified: April 2007

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 Intervention
Carotid Stenosis
Procedure: contrast-enhanced magnetic resonance angiography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis

Resource links provided by NLM:

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

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

Inclusion Criteria:

Carotid artery stenosis > 50%

  Contacts and Locations
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Please refer to this study by its identifier: NCT00131001

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

No publications provided Identifier: NCT00131001     History of Changes
Other Study ID Numbers: 99.203
Study First Received: August 16, 2005
Last Updated: October 17, 2008
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

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathological Conditions, Anatomical
Vascular Diseases processed this record on March 02, 2015