Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide in Patients Under Surveillance for Abdominal Aortic Aneurysms to Predict Rupture or Surgical Repair: the MA3RS Trial - MAR3S Trial

niversity of Edinburgh0 sites342 target enrollmentAugust 28, 2012

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2012

End Date

November 1, 2016

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Edinburgh

•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

•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).