Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography

Bayer12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Magnetic Resonance Angiography Peripheral Vascular Diseases Peripheral Arterial Diseases

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Hirosaki-shi, Aomori, Japan

Unnamed facility

Funai-gun, Kyoto, Japan

Unnamed facility

Hamamatsu, Shizuoka, Japan

Outcomes

Primary Outcomes

Diagnostic ability

Time frame: MRI image in blinded read

Secondary Outcomes

Visibility

Time frame: MRI image in blinded read

Diagnostic confidence

Time frame: MRI image in blinded read