DyeVert System and Contrast-induced Acute Kidney Injury (REMEDIALIV)
Contrast-induced Acute Kidney Injury, Acute Coronary Syndromes
About this trial
This is an interventional prevention trial for Contrast-induced Acute Kidney Injury focused on measuring acute kidney injury, Device: DyeVert™ system, percutaneous coronary intervention
Eligibility Criteria
Inclusion Criteria:
- Urgent or immediate (within 2 hours) coronary procedure with iodinated contrast media administration in the setting of an acute coronary syndrome:
ST-Elevation Myocardial Infarction (according to Fourth Universal Definition of Myocardial Infarction);
High-risk Non-ST-Elevation Myocardial Infarction (according to current guidelines):
- Refractory angina,
- Signs or symptoms of heart faiklure or new or worsening mitral regurgitation,
- Hemodynamic instability,
- Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy,
- Sustained ventricular tachycardia or ventricular fibrillation,
- Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation.
Exclusion Criteria:
- Women who are pregnant.
- Recent contrast media exposure: contrast media exposure within 48 hours.
- End-stage chronic kidney disease on chronic dialysis: both haemodialysis and peritoneal dialysis.
- Multiple myeloma.
- Current enrolment in any other study when enrolment in the REMEDIAL IV would involve deviation from either protocol.
Sites / Locations
- IRCCS Policlinico Multimedica
- Clinica MediterraneaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
DyeVert group
Control group
Patients will receive intravenous 0.9% sodium chloride as soon as in the catheterization laboratory. The hydration regimen will be defined according to the hemodynamic conditions and modulated according to the left ventricular end diastolic pressure (LVEDP). During the PCI the CM injection will be handled by the DyeVert TM system.
Patients will receive intravenous 0.9% sodium chloride as soon as in the catheterization laboratory. The hydration regimen will be defined according to the hemodynamic conditions and modulated according to the left ventricular end diastolic pressure (LVEDP). During the PCI the CM injection will be carried out by a conventional manual injection syringe. Strategies for limiting CM volume are: angiograms will be performed with injection of contrast using a 3-cm 3 syringe; this provides strict control of CM delivery by limiting the volume of contrast that can be administered in a single injection; catheters with sideholes will be strictly avoided during percutaneous intervention; when exchanging catheters, unused contrast is withdrawn from the catheter lumen (e.g., by back-bleeding through an opened ''Y''-connector or by aspirating residual contrast from the catheter using a syringe) ''tests'' with ''puffs'' of CM are discouraged.