Trials / Completed
CompletedNCT03671603
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
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,755 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iodixanol | 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. |
Timeline
- Start date
- 2018-11-05
- Primary completion
- 2021-06-07
- Completion
- 2021-06-07
- First posted
- 2018-09-14
- Last updated
- 2022-01-11
Locations
36 sites across 2 countries: China, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03671603. Inclusion in this directory is not an endorsement.