Trials / Completed
CompletedNCT00827788
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)
The Contrast Media and Nephrotoxicity Following Coronary Revascularization by Primary Angioplasty for Acute Myocardial Infarction. The CONTRAST-AMI Study.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 432 (estimated)
- Sponsor
- Ospedale San Donato · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.
Detailed description
This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iodixanol | Iso-osmolar contrast medium (Iodixanol) will be administered during PCI |
| DRUG | Iopromide | Low-osmolar contrast medium (Iopromide) will be administered during PCI |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-04-01
- First posted
- 2009-01-23
- Last updated
- 2010-11-16
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00827788. Inclusion in this directory is not an endorsement.