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

General Electric (GE)

Status: Completed

Conditions: Coronary Artery Disease; ST-segment Elevation Myocardial Infarction

Treatments: Drug: Iodixanol

Study type: Observational

Funder types: Industry

Identifiers

NCT03671603

VIS-16-07 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2,755 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,755 participants in 1 patient group

Iodixanol

Description:

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.

Treatment:

Drug: Iodixanol