Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium

Study Overview
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Brief Summary
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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.

Official Title
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The Association of Iodixanol (Visipaque) to Renal Function and Cardiac and Cerebrovascular Events in STEMI Patients Undergoing Primary PCI: A Prospective, Multi-National, Multi-Center, Open-Label, Observational Study

Conditions
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Coronary Artery Disease, ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Iodixanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria: The participant is over 18 years' old The participant with ST segment elevation myocardial infarction (STEMI) diagnosis has completed primary percutaneous coronary intervention (PCI) procedure and Visipaque was used as the contrast medium in the procedure The participant completed pre-procedural serum creatinine (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 The participant has signed and dated the written informed consent form Exclusion Criteria: Participants must be excluded from participating in this study if they meet any of the following criteria: The participant has any contraindications to Visipaque (e.g., manifest thyrotoxicosis, history of serious hypersensitivity reaction to iodinated contrast media) The participant is pregnant or lactating The participant has been previously enrolled in this study The participant is currently under renal dialysis The participant presents with a terminal (life expectation <1 month), serious, or life-threatening disease, or any medical or psychiatric condition, or any condition where study participation may compromise the management of the participant The participant has other reasons that in the judgement of the investigator is unsuitable for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Iodixanol<br>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. | Drug: Iodixanol<br>* 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.<br>* Other names: VISIPAQUE®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |