the Accuracy and Safety of Renal Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Study Details
Study Description
Brief Summary
This study is a single-center, prospective, controlled and diagnostic clinical trial to explore the effectiveness and safety of domestic polysaccharide superparamagnetic iron oxide injection for contrast-enhanced renal artery magnetic resonance. This study will enroll 40 patients scheduled for renal arteriography in China.The investigators will record the baseline data of patients after admission.Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle to assess renal artery stenosis.The related laboratory indexes will be reviewed at 72 h after Magnetic Resonance Imaging ,and then patients will receive renal angiography . The indexes were reexamined at 1 month and 3 months after magnetic resonance imaging. The investigators will Record all clinical adverse events. 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 investigators will Record all clinical adverse events in this study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EMRA Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography. |
Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.
|
Outcome Measures
Primary Outcome Measures
- the degree of renal artery stenosis [baseline]
Degree of renal artery stenosis assessed by Magnetic Resonance Imaging
- the degree of renal artery stenosis [baseline]
Degree of renal artery stenosis assessed by renal artery angiography
- change of hemoglobin level [baseline,72 hours,30 days,3 months]
hemoglobin examination of patients before and after examination to evaluate anemia.
- serum creatinine [baseline,72 hours,30 days,3 months]
serum creatinine examination of patients before and after examination to evaluate kidney function.
- Urine routine [baseline,72 hours,30 days,3 months]
Urine routine examination of patients before and after examination to evaluate kidney function.
- 24-hour urine biochemistry [baseline,72 hours,30 days,3 months]
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
- Retinol binding protein [baseline,72 hours,30 days,3 months]
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
- Neutrophil gelatinase-associated lipocalin [baseline,72 hours,30 days,3 months]
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
- Serum iron [baseline,72 hours,30 days,3 months]
Determination of serum iron before and after MRA to evaluate the changes of iron content in peripheral blood.
- Ferritin [baseline,72 hours,30 days,3 months]
Determination of serum ferritin before and after MRA to evaluate the changes of iron content in peripheral blood.
- Transferrin [baseline,72 hours,30 days,3 months]
Determination of serum transferrin before and after MRA to evaluate the changes of iron content in peripheral blood.
- Change of iron content in tissues between different time points [baseline,6 months]
Evaluation of tissue iron content by T1W MRI before and after MRA.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≧ 18 years, < 65 years;
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Patients who planned coronary angiography (hypertension 、renal failure、atherosclerosis）;
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Patients with normal renal function or CKD stage 1-3;
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Patients themselves or authorized families to sign informed consent voluntarily.
Exclusion Criteria:
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Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
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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 );
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Malignancies or other comorbid conditions with life expectancy less than 1 year;
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Pregnant or lactating woman;
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Hearing impaired persons;
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Cardiac function grade III-IV;
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History of coronary stenting or coronary artery bypass grafting;
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Patients who were taking other iron agents orally or intravenously;
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Patients with hemosiderin deposition or hemochromatosis;
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Patients with acute coronary syndromes;
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Any other patients that researcher deems it's unsuitable to be admitted.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210029 |
Sponsors and Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigators
- Principal Investigator: Chunjian Li, Dr,PhD, Study Principal Investigator
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 013