The following trial should be performed in patients with a stenosis of supraaortal and intracranial vessels, who are subjected to a plain cranial CT and CT angiography, which is considered to be a standard method in assessing the degree of stenosis. MedDRA version: 9.1 Level: LLT Classification code 10065141 Term: Vascular diagnostic procedure
Conditions
Sponsors
Institute for Diagnostic Radiology and Neuroradiology, Ernst-Moritz-Arndt University Greifswald
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: 18 - 80 years Scheduled for plain cranial CT and CTA of the supraaortal and intracranial vessels written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnancy and nursing mothers additional CT-examinations within the same study known hypersensitivity to iodine containing contrast agents known hypersensitivity to Gd-containing contrast agents hyperthyrodism advanced renal insufficiency (calculated GFR < 20mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the image quality and the intravascular enhancement using Gadolinium or iodine containing contrast media. To compare the nephrotoxicity of Gadobutrol (Gadovist®) versus Iodixanol (Visipaque™).;Secondary Objective: ;Primary end point(s): maximum intravascular peak enhancement in Hounsfield units (HU) serum creatinine on day 0 and 3 | — |
Countries
Germany
Outcome results
None listed