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

NCT05032937 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

domestic polysaccharide superparamagnetic iron oxide nanoparticle

Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY
  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Chunjian Li, Dr, PhD · Study Principal Investigator

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05032937 on ClinicalTrials.gov