Trial Condition(s):
Magnetic Resonance Angiography, Peripheral Vascular Diseases
Magnevist (SH L 451A) intra-individual dose comparison study in Magnetic Resonance Angiography
Bayer Identifier:
91396
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hirosaki Daigaku Igakubu Fuzoku Byoin Hirosaki-shi, Japan, 036-8563 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamamatsu Ikadaigaku Igakubu Fuzoku Byoin Hamamatsu-shi, Japan, 431-3192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koritsu Nantan Byoin Funai-gun, Japan, 629-0197 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evaluation of a single intravenous injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in patients with arterial disease in the abdominal to leg regions in the ability of detecting of vessel abnormalities
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Diagnostic abilityTimeframe: MRI image in blinded read
Secondary Outcome
- VisibilityTimeframe: MRI image in blinded read
- Diagnostic confidenceTimeframe: MRI image in blinded read
Additional Information
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