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Multidetector Raw CT as a Single Tool in the Setting of Ischemic Stroke (COCASE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00708188
First Posted: July 2, 2008
Last Update Posted: July 26, 2013
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.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
This is a prospective study including acute ischemic stroke patients aged 18 to 90. Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and brain arteries are studied during the same acquisition. Results are compared with the standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS) and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify the stroke etiology correctly according to the TOAST classification in comparison with the standard methods.

Condition Intervention
Ischemic Stroke Device: Multidetector raw CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Multidetector Raw Computerized Tomography in the Etiological Analysis of Acute Ischemic Stroke: the "COCASE" Protocol.

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Ability of CT to classify the stroke etiology correctly (TOAST classification) in comparison to reference methods (MRA, DUS, TEE) [ Time Frame: classify the stroke etiology ]

Secondary Outcome Measures:
  • Ability of CT to detect the source of stroke in each etiological group. Reliability of CT in quantitative measures of artery stenosis, aortic atheroma, heart thrombus, heart tumors). Tolerance of CT [ Time Frame: detect the source of stroke ]

Enrollment: 49
Study Start Date: March 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multidetector raw CT Device: Multidetector raw CT
Multidetector raw CT

  Eligibility

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:

  • Acute (< 1 week) ischemic stroke patient aged 18 to 90
  • Informed consent obtained
  • Presence of health insurance

Exclusion Criteria:

  • Pregnancy or absence of efficient contraceptive method
  • Allergy
  • Allergy to contrast material
  • Asthma
  • Renal failure (blood creatinine > 130 µmoles/l, creatinine clearance < 80 ml/mn according to Cockroft method)
  • Myeloma
  • Hyperthyroidism (uncontrolled)
  • Difficulties to synchronize CT to heart rhythm
  • Contra-indication to TEE or MRI
  • Absence or retirement of informed consent
  • Absence of health insurance
  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): NCT00708188


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

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00708188     History of Changes
Other Study ID Numbers: 2006.431/24
First Submitted: June 30, 2008
First Posted: July 2, 2008
Last Update Posted: July 26, 2013
Last Verified: July 2013

Keywords provided by Hospices Civils de Lyon:
Stroke, ischemic, etiology, TOAST, CT, multidetector

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia