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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multidetector raw CT
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke focused on measuring Stroke, ischemic, etiology, TOAST, CT, multidetector

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Cardiologique Louis Pradel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multidetector raw CT

Arm Description

Outcomes

Primary Outcome Measures

Ability of CT to classify the stroke etiology correctly (TOAST classification) in comparison to reference methods (MRA, DUS, TEE)

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

Full Information

First Posted
June 30, 2008
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00708188
Brief Title
Multidetector Raw CT as a Single Tool in the Setting of Ischemic Stroke
Acronym
COCASE
Official Title
Evaluation of Multidetector Raw Computerized Tomography in the Etiological Analysis of Acute Ischemic Stroke: the "COCASE" Protocol.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Stroke, ischemic, etiology, TOAST, CT, multidetector

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidetector raw CT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Multidetector raw CT
Intervention Description
Multidetector raw CT
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DOUEK Philippe, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21062925
Citation
Boussel L, Cakmak S, Wintermark M, Nighoghossian N, Loffroy R, Coulon P, Derex L, Cho TH, Douek PC. Ischemic stroke: etiologic work-up with multidetector CT of heart and extra- and intracranial arteries. Radiology. 2011 Jan;258(1):206-12. doi: 10.1148/radiol.10100804. Epub 2010 Nov 9.
Results Reference
result

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

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