Evaluation of carotid atheroma with contrast enhanced magnetic resonance imaging - Evaluation of carotid atheroma with contrast enhanced MRI

Cambridge University Hospitals Foundation Trust0 sites100 target enrollmentJanuary 11, 2008

Overview

No summary available.

Registry

who.int

Start Date

January 11, 2008

End Date

July 10, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Cambridge University Hospitals Foundation Trust

•1\. Carotid stenosis of \>40% diagnosed on carotid ultrasound or angiogram.
•2\. Male or female aged 18 to 90 years of age. Female subjects must be of non\-childbearing potential (post\-menopausal females who have been amenorrhoeic for more than one year, or pre\-menopausal females with a documented hysterectomy or bilateral oophorectomy).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•Contraindication to MR imaging including but not limited to:
•a) intracranial aneurysm clips (except Sugita) with an appropriate operative conformation
•b) history of intra\- orbital metal fragments that have not been removed by an medical doctor, pacemakers and non\-MR compatible heart valves
•c) inner ear implants
•d) history of claustrophobia in MR
•e) Participation in more than 2 clinical studies at any one time
•Other contraindications:
•1\. Known renal impairment
•2\. Previous renal or liver transplant
•3\. History of clinically significant atopy (e.g. anaphylaxis, skin rash to medication or topical therapies, hypersensitivity to iodinated contrasts, gadolinium based compunds, allergies to food (e.g. shellfish), bronchial asthma, etc.)