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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECMR<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Plaque Stability