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There were few eligible subjects from other centers.
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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.
To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iopamiro-370 | Active Comparator |
| |
| Visipaque 320 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopamidol injection 76% | Drug | Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution |
| Measure | Description | Time Frame |
|---|---|---|
| contrast-induced nephropathy | Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure | 48-72 h |
| Measure | Description | Time Frame |
|---|---|---|
| A relative increase in serum creatinine | A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure. | 48-72 h |
| A relative increase in estimated glomerular filtration rate (eGFR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiyan Chen, MD | chen-jiyan@163.com | Study Chair |
| Yingling Zhou, MD | Guangdong Cardiovascular Institute,Guangdong General Hospital | Study Director |
| Yong Liu, MD | liuyongyisheng@126.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Cardiovascular Institute,Guangdong General Hospital | Guangzhou | Guangdong | 510100 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
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| Guangzhou General Hospital of Guangzhou Military Command |
| OTHER |
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| iodixanol | Drug | Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution |
|
A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure |
| 48-72 h |
| An absolute increase in serum creatinine | An absolute increase in serum creatinine within 48-72 h of contrast exposure | 48-72 h |
| Major adverse clinical events | Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke | 1 month |
| Major adverse clinical events | Major adverse clinical events: death, requiring renal replacement therapy, acute myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke | 1 year |
| An significant increase in serum creatinine | An significant increase in serum creatinine was defined as an increase in serum creatinine of more than 1.0 mg/dl from the baseline within 48-72 h of contrast exposure | 48-72 h |
| Contrast-Induced Acute Kidney Injury | Contrast-Induced Acute Kidney Injury was defined as an increase in serum creatinine concentration of more than 0.3 mg/dL from the baseline value at 48 hours after administration of the contrast exposure or the need for dialysis | 48 h |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |