Steno-occlusive Disease
Conditions
Brief summary
This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.
Interventions
DRUGMultihance
0.5 Molar, single injection at 0.2 mL/kg
DRUGvasovist
0.25 molar single injection 0.03 ml/kg
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known or suspected renovascular disease based on one of the following criteria: * severe hypertension * hypertension refractory to standard therapy * abrupt onset of moderate to severe hypertension at age \< 35 years * normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension * unexplained by stable elevation of serum creatinine \> 2Mg/dL * positive findings for stenosis from another imaging modality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity compared to DSA | post dose |
Secondary
| Measure | Time frame |
|---|---|
| accuracy and predictive values; inter-reader agreement for diagnostic performance | post dose |
Countries
Italy
Outcome results
None listed