Multidetector Raw CT as a Single Tool in the Setting of Ischemic Stroke - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment

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 ]

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708188

Contacts


Contact: DOUEK Philippe, MD	+33472357353	douek@creatis.univ-lyon1.fr

Locations


France
	Hôpital Cardiologique Louis Pradel	Recruiting
	Bron, France, 69677
	Contact: DOUEK Philippe, MD +33472357353 douek@creatis.univ-lyon1.fr
	Sub-Investigator: BOUSSEL Loïc
	Sub-Investigator: TROUILLAS Paul
	Sub-Investigator: NIGHOGHOSSIAN Norbert
	Sub-Investigator: DEREX Laurent
	Sub-Investigator: DERUMEAUX Geneviève
	Sub-Investigator: BARTHELET Martine
	Sub-Investigator: HERMIER Marc
	Sub-Investigator: TAHON Florence
	Sub-Investigator: GAMONDES Delphine

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 ( Pr Philippe DOUEK )
Study ID Numbers:	2006.431/24
First Received:	June 30, 2008
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00708188
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Hospices Civils de Lyon:

Stroke, ischemic, etiology, TOAST, CT, multidetector

Study placed in the following topic categories:

Cerebral Infarction

Stroke

Vascular Diseases

Brain Ischemia

Central Nervous System Diseases

Brain Infarction

Ischemia

Brain Diseases

Infarction

Cerebrovascular Disorders

Additional relevant MeSH terms:

Pathologic Processes

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00708188