IOinated contrast DILution in digital subtraction angiography of the limb:
a randomized controlled trial with three different concentrations of iodine

Peripheral arterial disease is a common manifestation of systemic
atherosclerosis. Almost 10% has peripheral arterial disease on the age of 60
years, which can present as intermittent claudication or critical limb
ischemia. The interventional radiologist can perform a digital subtraction
angiography to treat stnoses or occlusions. This procedure uses iodinated
contrast. In the acadimc medical center a contrast concentration of 300 mg of
jodium per ml is used. This contrast is associated with complications, such as
contrast induced nephropathy or allergic reactions. Research for alternative
contrast media, such as carbon dioxide and gadolinium, do not give the desired
results to replace the iodinated contrast. To decrease the risk for
complications lowering the contrast concentration is another option. The only
question is whether the imaging quality is adequate enough for proper
diagnostics and treatment. Therfore we want to study what influences a lowered
iodinated contrast concentration has on imaging quality compared to the
currently used concentration.

To compare the confidence of the interventional radiologist in diagnosing and
treating arterial stenoses and occlusions by digital subtraction angiography
with contrast concentrations of 300, 240 and 140 mg iodine per ml. Also, we
will compare the imaging quality at these different concentrations.

Prospective, three-armed, double-blind study that evaluates the imaging quality
of three different iodinated contrast concentrations on digital subtraction
angiography in patients with peripheral arterial disease.

The additional burden for the patient is the completion of the baseline
questionnaire. The patient will be asked to return to the hospital two to three
days after the angiography for withdrawal of blood, so it can be determined
whether there is contrast-induced nephropathy. The risks of participation to
this study is also limited. By allocating lower iodinated contrast
concentrations, there is a chance that imaging quality is poor and the
radiologist decides to switch to the standard concentration. If this happens,
the patient is at risk that more contrast will be administered than would have
been done if the patient was not part of this study. This additional exposure
could lead to contrast-induced nephropathy and allergic reactions.