Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2008-008491-13 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ospedale Le Scotte | OTHER |
| Ospedale della Misericordia - Grosseto | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iodixanol | Active Comparator | Iso-osmolar contrast medium (Iodixanol) will be administered during PCI |
|
| iopromide | Active Comparator | Low-osmolar contrast medium (Iopromide) will be administered during PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol | Drug | Iso-osmolar contrast medium (Iodixanol) will be administered during PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Contrast Induced Nephropathy (CIN) between the two study groups, defined as relative increase of serum Creatinine of 25% or more from basal values | days 1, 2, 3, and at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| TIMI grade flow | before and after primary PCI | |
| Corrected TFC (TIMI frame count) | after primary PCI | |
| TMPG (TIMI Myocardial Perfusion Grade) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonardo Bolognese, MD, FESC | Ospedale SanDonato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Department, Ospedale S.Donato | Arezzo | AR | 52100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19829124 | Derived | Bolognese L, Falsini G, Grotti S, Limbruno U, Liistro F, Carrera A, Angioli P, Picchi A, Ducci K, Pierli C. The contrast media and nephrotoxicity following coronary revascularization by primary angioplasty for acute myocardial infarction study: design and rationale of the CONTRAST-AMI study. J Cardiovasc Med (Hagerstown). 2010 Mar;11(3):199-206. doi: 10.2459/JCM.0b013e32833186a4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Iopromide | Drug | Low-osmolar contrast medium (Iopromide) will be administered during PCI |
|
|
| after PCI |
| LFR slope (load to function slope) | after primary PCI |
| MACE | 1, 6, 12 months |
| absolute increase in serum Creatinine | days 1, 2, 3, and at discharge |
| relative increase in serum creatinine of 50% or more | days 1, 2, 3, and at discharge |
| ID | Term |
|---|---|
| C044834 | iodixanol |
| C038192 | iopromide |
Not provided
Not provided
Not provided