Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Retinol binding protein
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ECMR
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.
Intervention: domestic polysaccharide superparamagnetic iron oxide nanoparticle (Drug)
Outcomes
Primary Outcomes
Retinol binding protein
Time Frame: baseline,72 hours,30 Days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Blood routine
Time Frame: baseline,72 hours,30 Days,3 months
Blood routine examination of patients before and after examination to evaluate general condition of patients.
The degree of coronary artery stenosis
Time Frame: 72 hours
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Plaque stability of coronary atherosclerotic plaques
Time Frame: 72 hours
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Blood biochemistry
Time Frame: baseline,72 hours,30 Days,3 months
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Urine routine
Time Frame: baseline,72 hours,30 Days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
Time Frame: baseline,72 hours,30 Days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
Time Frame: baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Serum iron
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Ferritin
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Transferrin
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Change of iron content in tissues between different time points
Time Frame: baseline,6 months
Evaluation of tissue iron content by T1W MRI before and after ECMR.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chunjian Li
Dr., MD, Ph.D, Director of CCU Ward
The First Affiliated Hospital with Nanjing Medical University