This is an open-label, single-center, single-dose study aims to evaluate the effect and safety of polymeric superparamagnetic iron oxide in cardiovascular magnetic resonance imaging for diabetic patients with concomitant chronic kidney disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Polysaccharide superparamagnetic iron oxide injection can be used for the treatment of iron-deficiency anemia and for magnetic resonance imaging enhancement.
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The number of vascular segments with lesions
The number of vascular segments with lesions after administration
Time frame: 0 hour after administration
Lesion length
Vascular lesion length
Time frame: 0 hour after administration
Degree of vascular stenosis
Vascular stenosis degree
Time frame: 0 hour after administration
Image quality scores
Vascular image quality was scored on a 4-point scale. 1 = Vessels not assessable due to poor image quality; 2 = Vessels visualized but only gross features (size/patency) confidently assessable; 3 = Vessels well defined and evaluable for structural pathology with high confidence; 4 = Excellent vessel definition with sharp borders such that fine details can be evaluated with high confidence.
Time frame: 0 hour after administration
Myocardium T1 values
Changes from baseline in the longitudinal relaxation value of myocardial tissue.
Time frame: 0 hour after administration
Signal-to-noise ratio
The strength of a signal relative to the background noise.
Time frame: 0 hour after administration
Contrast-to-noise ratio
The visibility and distinguishability of structures or features of interest in an image in the presence of noise.
Time frame: 0 hour after administration
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Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 24 hours after administration
Serum iron
Changes from baseline in the amount of circulating iron that is bound to transferrin and freely circulate in the blood.
Time frame: Baseline up to 24 hours after administration
Serum ferritin
Changes from baseline in the concentration of plasma (or serum) ferritin.
Time frame: Baseline up to 30 days and 60 days after administration
Total iron-binding capacity
Changes from baseline in the total amount of iron that can be bound by transferrin proteins in the blood.
Time frame: Baseline up to 30 days and 60 days after administration
Serum transferrin saturation
Changes from baseline in the value of serum iron divided by the total iron-binding.
Time frame: Baseline up to 30 days and 60 days after administration