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

Phase 1

• Conditions: Carotid artery atheroma; MedDRA version: 9.1 Level: LLT Classification code 10060963 Term: Arterial disorder

• Registration Number: EUCTR2007-007673-23-GB
• Lead Sponsor: Cambridge University Hospitals Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-11
• Study Completion: 2012-07-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified