- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00708188
Multidetector Raw CT as a Single Tool in the Setting of Ischemic Stroke (COCASE)
May 23, 2019 updated by: Hospices Civils de Lyon
Evaluation of Multidetector Raw Computerized Tomography in the Etiological Analysis of Acute Ischemic Stroke: the "COCASE" Protocol.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69677
- Hôpital Cardiologique Louis Pradel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multidetector raw CT
|
Multidetector raw CT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
classify the stroke etiology
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
detect the source of stroke
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DOUEK Philippe, MD, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 30, 2008
First Submitted That Met QC Criteria
June 30, 2008
First Posted (Estimate)
July 2, 2008
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006.431/24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.