Medical condition: indication for computed tomographic angiography of the peripheral arteries, in particular for diagnosis of peripheral arterial disease
Conditions
Sponsors
Bracco ALTANA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Indication for Computed Tomographic Angiography (CTA) - Patient is adult (age = 18 years), conscious and co-operative - Written Informed Consent to participate in the study 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known aortic aneurysm - Major endoprosthesis, which could bias the diagnostic accuracy of MDCTA - Hyperthyroidism (TSH below 0.3 mU/L) - Renal insufficiency (serum creatinine > 1.5 mg/dL) - Hypersensitivity to iodinated contrast media or significant allergic disposition - Insulin-dependent diabetes mellitus, or metformin medication (discontinuation for 48 h enables CT examination of patients with normal renal function) - Known pheochromocytoma or paraproteinaemia - Acute stroke or cerebral oedema - Known Epilepsy; currently active - Planned radioactive iodine therapy - Participation in a clinical trial within the past 30 days - Previous participation in this clinical trial - Alcohol or drug abuse - Patient is female and pregnant or nursing - Patient is female and the possibility of pregnancy cannot be excluded from one of the following points: · surgical sterilization (method has to be recorded on medical history form) · confirmed post-menopausal (with minimum 1-year history without menstruation) · negative pregnancy test (confirmed via ß-HCG measurement) - Patient is institutionalized by law - Circumstances that would significantly decrease the chance of obtaining reliable data or of achieving the study objectives according to the Investigator’s final opinion - Peripheral vein conditions, which would not allow for the required fast administration of contrast agents (18 gauge needle)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantitatively compare the vascular opacification in terms of contrast density (HU) in MDCTA of peripheral arteries between a long bolus injection of Iomeprol 300 and a short bolus injection of Iomeprol 400 at equal iodine amounts.;Secondary Objective: To compare between the Iomeprol 300 and Iomeprol 400 injection protocols: · Contrast density (HU) in certain arterial and venous vessel segments · Qualitative evaluations of vascular opacification · Overriding of the contrast bolus · Venous overlap;Primary end point(s): The primary efficacy variable will be the individual average over all contrast density measurements (HU) of arterial segments | — |
Countries
Germany
Outcome results
None listed