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

Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≧ 18 years, < 75 years;
• Patients who planned coronary angiography ;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECMR; Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of coronary artery stenosis	Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.	baseline
The degree of coronary artery stenosis	Degree of coronary artery stenosis assessed by quantitative coronary angiography.	72 hours
Plaque stability of coronary atherosclerotic plaques	Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.	baseline
Plaque stability of coronary atherosclerotic plaques	Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.	72 hours
Blood routine	Blood routine examination of patients before and after examination to evaluate general condition of patients.	baseline,72 hours,30 Days,3 months
Blood biochemistry	Blood biochemistry examination of patients before and after examination to evaluate liver function.	baseline,72 hours,30 Days,3 months
Urine routine	Urine routine examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
24-hour urine biochemistry	24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
Retinol binding protein	Retinol binding protein examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin	Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
Serum iron	Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 Days,3 months
Ferritin	Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 Days,3 months
Transferrin	Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.	baseline,72 hours,30 Days,3 months
Change of iron content in tissues between different time points	Evaluation of tissue iron content by T1W MRI before and after ECMR.	baseline,6 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Principal Investigator: Chunjian Li, Dr, PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide; Contrast-Enhanced Magnetic Resonance; Plaque Stability
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 012 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No