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

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single-center, prospective, controlled and diagnostic clinical trial to explore the effectiveness and safety of domestic polysaccharide superparamagnetic iron oxide injection for contrast-enhanced renal artery magnetic resonance. This study will enroll 40 patients scheduled for renal arteriography in China.The investigators will record the baseline data of patients after admission.Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal artery stenosis.The related laboratory indexes will be reviewed at 72 h after Magnetic Resonance Imaging ,and then patients will receive renal angiography . The indexes were reexamined at 1 month and 3 months after magnetic resonance imaging. The investigators will Record all clinical adverse events. 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 investigators will Record all clinical adverse events in this study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; School of Biological Science and Medical Engineering, Southeast University; School of Biomedical Engineering and Information, Nanjing Medical University

Criteria

Inclusion Criteria:

• Age ≧ 18 years, < 65 years;

• Patients who planned coronary angiography (hypertension 、renal failure、atherosclerosis）;

• Patients with normal renal function or CKD stage 1-3;

• Patients themselves or authorized families to sign informed consent voluntarily.

Exclusion Criteria:

• Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;

• Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );

• Malignancies or other comorbid conditions with life expectancy less than 1 year;

• Pregnant or lactating woman;

• Hearing impaired persons;

• Cardiac function grade III-IV;

• History of coronary stenting or coronary artery bypass grafting;

• Patients who were taking other iron agents orally or intravenously;

• Patients with hemosiderin deposition or hemochromatosis;

• Patients with acute coronary syndromes;

• Any other patients that researcher deems it's unsuitable to be admitted.