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| ID | Type | Description | Link |
|---|---|---|---|
| VIS-16-07 | Other Identifier | GE HealthCare |
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The purpose of this study is to prospectively observe the incidence rate of acute kidney injury (AKI), major adverse renal and cardiovascular events (MARCE) in participants who were diagnosed with ST-segment elevation myocardial infarction (STEMI) and have completed primary percutaneous coronary intervention (PCI) procedure following an injection of iso-osmolar contrast medium iodixanol (Visipaque) during the in-hospital period and up to 30 days post-PCI follow-up period. The study will provide a better safety profile of Visipaque as the contrast medium in PCI procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodixanol | Participants will receive Iodixanol 270 mg I/ml or Iodixanol 320 mg I/ml injection as a part of routine clinical practice at the medical discretion of the physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol | Drug | Iodixanol 270 mgI/ml or 320 mg I/ml injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque | AKI which is defined as a serum creatinine (SCr) increase of ≥ 0.3 mg/dL (≥ 26.4 umol/L) or increase to ≥150% (≥1.5-fold) from baseline values within 48-72 hours. | Within 48-72 hours post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Incidence Rate of MARCE in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI | MARCE includes cardiac death, re-infarction, target lesion revascularization (TLR), stent thrombosis, unstable angina, stroke, transient ischemic attack (TIA), AKI, renal failure requiring dialysis. | Within 72 hours post-PCI |
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Inclusion Criteria:
Participants may be included in the study if they meet all of the following criteria:
Exclusion Criteria:
Participants must be excluded from participating in this study if they meet any of the following criteria:
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The study population will be adult participants with STEMI diagnosis and have completed primary PCI procedure using Visipaque as contrast medium. The participants should complete pre-procedural SCr test at the same hospital where PCI procedure was conducted, and the SCr test should be conducted with the same methodology before and after the procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaifeng Central Hospital | Kaifeng | Contact: | China | |||
| The Second Affiliated Hospital of Chongqing Medical University |
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|
| Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI | MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis. | Within 72 Hours post-PCI |
| Assessment of the Incidence Rate of MARCE (Except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 days Post-PCI | MARCE includes cardiac death, re-infarction,TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis. | From 72 hours to 30 days post-PCI |
| Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 Days Post-PCI | MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis. | From 72 hours to 30 Days post-PCI |
| All-Cause Mortality of STEMI Participants Within 30 days after primary PCI | From Baseline up to 30 days post-PCI |
| Chongqing |
| Gansu |
| China |
| Lanzhou University Second Hospital | Lanzhou | Gansu | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | China |
| Dongguan Kanghua Hospital | Guangdong | Guangdong | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | China |
| Hebei General Hospital | Shijiazhuang | Hebei | China |
| Shijiazhuang First Hospital Central Hospital Campus | Shijiazhuang | Hebei | China |
| Shijiazhuang First Hospital | Shijiazhuang | Hebei | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital of Henan University of CM | Zhengzhou | Henan | China |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | China |
| Wuhan Central Hospital | Wuhan | Hubei | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Nanjing Jiangning Hospital | Nanjing | Jiangsu | China |
| People's Hospital of Jiangsu Province | Nanjing | Jiangsu | China |
| China-Japan Friendship Hospital of Jilin University | Changchun | Jilin | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | China |
| Ankang City Central Hospital | Ankang | Shaanxi | China |
| Linzi District People's Hospital | Linzi | Shandong | China |
| Shanxi Province Fenyang Hospital | Fenyang | Shanxi | China |
| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | China |
| Taiyuan Central Hospital | Taiyuan | Shanxi | China |
| Xi'an No.3 Hospital | Xi’an | Shanxi | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Ningbo First People's Hospital | Ningbo | Zhejiang | China |
| Shaoxing Hospital of Zhejiang University | Shaoxing | Zhejiang | China |
| Peking University First Hospital | Beijing | China |
| Wangjing Hospital of CACMS | Beijing | China |
| Shanghai Tongren Hospital | Shanghai | China |
| Shanghai Zhongshan Hospital | Shanghai | China |
| Tianjin Chest Hospital | Tianjin | China |
| Seoul National University Bundang Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
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