Magnetic resonance imaging (MRI) for abdominal aortic aneurysms to predict rupture or surgery: the MA3RS trial

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm; Circulatory System; Abdominal aortic aneurysm, ruptured

• Registration Number: ISRCTN76413758
• Lead Sponsor: niversity of Edinburgh / NHS Lothian (UK)

Brief Summary

1. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27056256 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28720724 3. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29406857 (added 16/07/2019) 4. 2019 biomarker study results in (added 10/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-04
• Study Completion: 2016-09-07
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

1. Abdominal aortic aneurysms measuring =40 mm 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

Exclusion Criteria

1. Patients expected to, or already received, imminent elective or emergency surgical or endovascular repair
2. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire
3. Patients refusing or unable to give informed consent
4. Woman with child-bearing potential and who are breastfeeding 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 known iron overload, hemochromatosis, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency)
9. Contraindication to Iodine

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of aneurysm rupture or aortic aneurysm repair

Secondary Outcome Measures

Name	Time	Method
<br> 1. The rate of aneurysm rupture<br> 2. The rate of surgical repair of the aneurysm<br> 3. Aneurysm growth rate<br> 4. All-cause and aneurysm-related mortality<br> 5. We will conduct exploratory analyses examining the interactions between mural USPIO uptake, biomechanical stress, clinical risk factors and serum biomarkers of extracellular matrix turnover and inflammation.<br><br> Clinicians involved directly with patient surveillance and care will be blinded to the magnetic resonance imaging findings of mural USPIO uptake.<br>