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

Ischemic Stroke Clinical Trial

— COCASE  

Official title:

Evaluation of Multidetector Raw Computerized Tomography in the Etiological Analysis of Acute Ischemic Stroke: the "COCASE" Protocol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708188
• Other study ID #: 2006.431/24
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Multidetector raw CT
Multidetector raw CT

Locations

Country	Name	City	State
France	Hôpital Cardiologique Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

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/rad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of CT to classify the stroke etiology correctly (TOAST classification) in comparison to reference methods (MRA, DUS, TEE)		classify the stroke etiology
Secondary	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		detect the source of stroke