Carotid artery atheroma MedDRA version: 9.1 Level: LLT Classification code 10060963 Term: Arterial disorder
Conditions
Interventions
Trade Name: Vasovist
Pharmaceutical Form: Solution for injection
Other descriptive name: Gadofoveset trisodium
Concentration unit: mmol/ml millimole(s)/
Sponsors
Cambridge University Hospitals Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.) 4. Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To attempt to optimise contrast enhanced magnetic resonance imaging of patients with carotid artery narrowing and aiding assessment of risk of stroke in these patients.; Secondary Objective: To establish if contrast enhanced magnetic resonance imaging using a stronger magnetic field (at 3 Tesla) superior to the more commonly used clinical magnetic field of 1.5T. To demonstrate if contrast enhanced sequences that image the carotid artery at 1.5T and 3.0T show adequate repeatability. Optimisation of contrast enhanced signal characteristics at 1.5T and 3.0T using different surface coil arrays. ;Primary end point(s): When the 100th patient has been images and the data analysis is complete. | — |
Countries
United Kingdom
Outcome results
None listed