Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
Phase 2
Completed
- Conditions
- Magnetic Resonance AngiographyPeripheral Vascular DiseasesPeripheral Arterial Diseases
- Interventions
- Registration Number
- NCT00652418
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) - Arm 2 Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) -
- Primary Outcome Measures
Name Time Method Diagnostic ability MRI image in blinded read
- Secondary Outcome Measures
Name Time Method Visibility MRI image in blinded read Diagnostic confidence MRI image in blinded read