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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00708188
First received: June 30, 2008
Last updated: July 25, 2013
Last verified: July 2013
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00708188     History of Changes
Other Study ID Numbers: 2006.431/24
Study First Received: June 30, 2008
Last Updated: July 25, 2013
Health Authority: France: Direction Générale de la Santé

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

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

ClinicalTrials.gov processed this record on October 20, 2014