The use of magnetic resonance imaging and a novel contrast agent to predict rupture or need for surgical repair in patients under surveillance with abdominal aortic aneurysms.

Phase 1

• Conditions: Abdominal Aortic Aneurysm; MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2012-002448-25-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-28
• Study Completion: 2016-11-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 342

Inclusion Criteria

1. Abdominal aortic aneurysms measuring =40mm in anteroposterior diameter on ultrasound scanning. 2. Age =40 years. Patients with abdominal aortic aneurysms less than 40 years may have a connective tissue disorder and a different aetiology to their disease.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 115
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 234

Exclusion Criteria

1. Patients expected to undergo imminent elective or emergency surgical or endovascular repair. 2. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire, which includes but not limited to: - intracranial aneurysm clips (except Sugita) or other metallic objects - history of intra-orbital metal fragments that have not been removed - pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves - inner ear implants - history of claustrophobia in MR - allergy to MRI contrast enhancement agent 3. Patients refusing or unable to give informed consent 4. Woman with child-bearing potential will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant). 5. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy (life expectancy < 2 years). 6. Renal dysfunction (eGFR =30 mL/min/1.73m2). 7. Polycythemia. 8. Contraindication to ferumoxytol (evidence of iron overload, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency).

Study & Design

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