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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMR | Experimental | Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunjian Li, Dr, PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37463240 | Derived | 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. | |
| 37341530 |
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|
| 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 |
| 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. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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