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The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iopromide | Experimental | Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation |
|
| Iodixanol | Active Comparator | Drug: Visipaque 320 mgl/ml, injection of intra-artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopromide (Ultravist) | Drug | Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. | day 3 postreatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients developing acute renal failure. | day 30 postreatment | |
| Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25% | days 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yundai Chen, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing CHAO-YANG Hospital | Beijing | Beijing Municipality | 100020 | China | ||
| General Hospital of Armed Police Forces |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23045301 | Derived | Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126. |
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| Iodixanol (Visipaque) | Drug | Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM |
|
|
| Beijing |
| Beijing Municipality |
| 100039 |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| Beijing Shi Jing Shan Hospital | Beijing | Beijing Municipality | 10040 | China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| Chinese PLA general hospital | Beijing | Beijing Municipality | 100853 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | 430022 | China |
| The Second Hospital of Xiangya | Changsha | Hunan | 410013 | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | 130033 | China |
| The First Hospital of Jilin University | Changchun | Jinlin | 130021 | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Renji Hospital affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 200127 | China |
| Changhai Hospital affiliated to the second millitary medical university | Shanghai | Shanghai Municipality | 200433 | China |
| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | 300051 | China |
| Teda International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
| The Second Hospital Affiliated to Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| Sir Run Run Shaw Hospital affiliated to Zhejiang | Hangzhou | Zhejiang | 310016 | China |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| C038192 | iopromide |
| C044834 | iodixanol |
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