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Clinical Trials/ISRCTN76413758
ISRCTN76413758
Completed
未知

Magnetic Resonance Imaging using ultrasmall supermagnetic particles of iron oxide in patients under surveillance for abdominal aortic aneurysms to predict rupture or surgical repair

niversity of Edinburgh / NHS Lothian (UK)0 sites342 target enrollmentMarch 4, 2013
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ConditionsAbdominal Aortic AneurysmCirculatory SystemAbdominal aortic aneurysm, ruptured

Overview

Phase
未知
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm
Sponsor
niversity of Edinburgh / NHS Lothian (UK)
Enrollment
342
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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)
Registry
who.int
Start Date
March 4, 2013
End Date
September 7, 2016
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
niversity of Edinburgh / NHS Lothian (UK)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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