drugset / Trial / NCT02398266

Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

NCT02398266

Phase 2 Unknown 55 enrolled Oregon Health and Science University
Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.

Timeline

Start
2016-08-01
Primary completion
2018-07-01
Completion
2018-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Perflubutane Diagnostic / imaging agent