Comparision between two diagnostic methods (DSA and MRA) to evaluate supraaortale arteries using three different contrast mediums MedDRA version: 9.1 Level: LLT Classification code 10007683 Term: Carotid angiography MedDRA version: 9.1 Level: LLT Classification code 10057784 Term: MRI angiography MedDRA version: 9.1 Level: LLT Classification code 10065324 Term: Digital subtraction angiography
Conditions
Interventions
Trade Name: Vasovist
Product Name: Gadofosveset Trinatriumsalz
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadofosveset Trinatriumsalz
CAS Number: 211570-55-7
Concentration unit:
Sponsors
University of Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male and female patients aged 18- 75 years - written, voluntary informed consent - patients are able to unterstand the meaning and consequences of the clinical trial - Indication MRT, MRA/DSA to represent the supraaortale vessels - GFR > or equal 60 ml/min (Cockroft Gault) - TSH normal range 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: - MRT is not possible (e.g. cardiac pacemacer, cochlea implant etc.) - known or suspected pregnancy - breastfeeding women - Recent intracerebrale bleeding with suspected aneurysm or AV-malformation (has to be ruled out by CT, native) - Known anaphylactic or anaphylactoid reaction in history - life-threatening or haemodynamic instability - inadequate renal function - thyroid overactivity or hypothyreoidism - seizure disorder - untreated hypocaliaemia - Known history of HIV infection or chronic hepatitis B or C infection - participation in any other clinical trial within the last 3 months - alcohol and/or substance abuse - patients, who need an emergency therapy/current therapeutic intervention in the area that is to be tested within 24 hours following the initial diagnostics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the diagnostic specificity between the two diagnostic methods DSA (with Solutrast) as standard and high-contrast MRA (with Vasovist) to evaluate supraaortales arteries;Secondary Objective: - Quantification of the picture used contrast medium Vasovist in atheromatous degeneration of carotid bifurcation and correlation with clinical symptoms - comparison of the late vessel wall enhancement of Magnevist and Vasovist 24 hours after application of contrast medium - correlation of the diagnostic results of MRA used extracellular contrast medium Magnevist and the intravascular contrast medium Vasovist - Safety and tolerance of Vasovist in MRA of spraaortale arteries - Safety of Vasovist concerning renal function (GFR of creatinine and cystatin C);Primary end point(s): Comparison of the diagnostic specificity between the two diagnostic methods DSA (with Solutrast) as standard and high-contrast MRA (with Vasovist) to evaluate supraaortales arteries | — |
Countries
Germany
Outcome results
None listed