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

NCT05032937 | Completed Phase 1 DMC

• 1 other identifier: 012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Heart Disease

Keywords

Ultrasmall Superparamagnetic Particles of Iron Oxide; Contrast-Enhanced Magnetic Resonance; Plaque Stability

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (1)

ECMR

EXPERIMENTAL

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

Interventions

domestic polysaccharide superparamagnetic iron oxide nanoparticle DRUG

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.

ECMR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

• Dong Z, Si G, Zhu X, Li C, Hua R, Teng J, Zhang W, Xu L, Qian W, Liu B, Wang J, Wang T, Tang Y, Zhao Y, Gong X, Tao Z, Xu Z, Li Y, Chen B, Kong X, Xu Y, Gu N, Li C. Diagnostic Performance and Safety of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography. Circ Cardiovasc Imaging. 2023 Jul;16(7):580-590. doi: 10.1161/CIRCIMAGING.123.015404. Epub 2023 Jul 18.

  PMID: 37463240 DERIVED

• Kar A, Gupta S, Matilal A, Kumar D, Sarkar S. Nanotherapeutics for the Myocardium: A Potential Alternative for Treating Cardiac Diseases. J Cardiovasc Pharmacol. 2023 Sep 1;82(3):180-188. doi: 10.1097/FJC.0000000000001444.

  PMID: 37341530 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Chunjian Li, Dr, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., MD, Ph.D, Director of CCU Ward

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: September 2, 2021
• Study Start: October 13, 2021
• Primary Completion: November 5, 2022
• Study Completion: January 5, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)