Magnetic Resonance Angiography, Peripheral Arterial Diseases, Peripheral Vascular Diseases
Conditions
Keywords
Magnevist, Magnetic Resonance Angiography, Meglumine gadopentetate, Determination of effective dose in MRA
Brief summary
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.
Interventions
DRUGGadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
Magnevist at a dose of 0.1 mmol/kg
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
Exclusion criteria
* Patients with an ankle brachial pressure index (ABPI) of 0.3 or less * Patients with allergy to contrast media * Patients with serious hepatic impairment * Patients with serious renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic ability | MRI image in blinded read |
Secondary
| Measure | Time frame |
|---|---|
| Visibility | MRI image in blinded read |
| Diagnostic confidence | MRI image in blinded read |
Countries
Japan
Outcome results
None listed