drugset / Trial / NCT05032937

the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

NCT05032937

NaSingle-groupOpen-labelDiagnostic

Summary

This is a single-center, prospective, controlled and diagnostic clinical trial which will enroll 30 patients scheduled for coronary angiography in China.Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The main indicators of the study are the degree of coronary artery stenosis and the stability of coronary atherosclerotic plaque assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.

Timeline

Start
2021-10-13
Primary completion
2022-11-05
Completion
2023-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferumoxytol Diagnostic / imaging agent 3 mg/kg Intravenous