FeMRA in CKD study_version 1
Research type
Research Study
Full title
Use of Ferumoxytol enhanced Magnetic Resonance Angiography (FeMRA) for cardiovascular assessment in late-stage chronic kidney disease (CKD).
IRAS ID
211105
Contact name
Sokratis Stoumpos
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Conventional vascular imaging techniques are often either contra-indicated or only used with caution in chronic kidney disease (CKD) patients due to their relative invasiveness, risks and cost. Computed tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may precipitate significant worsening of renal function and even prompt the need for institution of dialysis. Additionally, CT has reduced accuracy for arterial diagnosis in the presence of arteriosclerotic calcification which is extremely common in these patients. Magnetic resonance angiography (MRA) in patients with end-stage renal disease (ESRD) using gadolinium-based contrast agents has been associated with the rare disease ‘nephrogenic systemic fibrosis’. Alternative imaging methods also have drawbacks: for example, this frail patient group has a higher risk of complications from conventional invasive catheter-based angiography and calcification interferes with duplex ultrasound assessment of the peripheral arterial vasculature. Other tests such as non-contrast MRA methods are less accurate and ultrasound is often not appropriate for evaluation of the deep vessels of the thorax, abdomen and pelvis.
Ferumoxytol is an ultrasmall superparamagnetic iron oxide (USPIO) compound which has been licensed in the USA and Canada as a treatment for anaemia, particularly for patients with kidney disease. There has been increasing interest in its properties as a MRI contrast agent.
We are proposing to apply novel techniques with MRA using Ferumoxytol whilst planning transplantation or haemodialysis for renal replacement therapy. The “Use of Ferumoxytol enhanced Magnetic Resonance Angiography for cardiovascular assessment in late-stage chronic kidney disease (FeMRA in CKD) study” is a single centre prospective cohort study designed to compare routinely used imagining techniques with FeMRA in patients with severely impaired renal function.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0099
Date of REC Opinion
14 Oct 2016
REC opinion
Further Information Favourable Opinion