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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032937
• Other study ID #: 012
• Status: Completed
• Phase: Phase 1
• Start date: October 13, 2021
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 5, 2023
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The degree of coronary artery stenosis	Degree of coronary artery stenosis assessed by quantitative coronary angiography.	72 hours
Primary	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
Primary	Plaque stability of coronary atherosclerotic plaques	Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.	72 hours
Primary	Blood routine	Blood routine examination of patients before and after examination to evaluate general condition of patients.	baseline,72 hours,30 Days,3 months
Primary	Blood biochemistry	Blood biochemistry examination of patients before and after examination to evaluate liver function.	baseline,72 hours,30 Days,3 months
Primary	Urine routine	Urine routine examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
Primary	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
Primary	Retinol binding protein	Retinol binding protein examination of patients before and after examination to evaluate kidney function.	baseline,72 hours,30 Days,3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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