DyeVert System and Contrast-induced Acute Kidney Injury
NCT ID: NCT04714736
Last Updated: 2024-03-05
Study Results
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Basic Information
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COMPLETED
NA
522 participants
INTERVENTIONAL
2020-02-10
2023-12-31
Brief Summary
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Patients with ACS scheduled for urgent/immediate coronary angiography/angioplasty will be enrolled and randomized into 2 groups: 1) DyeVert group (CM injection will be handled by the DyeVert TM system), and 2) Control group (CM injection will be carried out by a conventional manual injection syringe).
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Detailed Description
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METHODS All patients with ACS scheduled for urgent/immediate coronary angiography/angioplasty will be screened for inclusion/exclusion criteria. Diagnosis of ACS (both ST-Elevation Myocardial Infarction \[STEMI\] and high-risk Non-ST-Elevation Myocardial Infarction \[Non-STEMI\]) will be established in accordance with guidelines, including a typical chest pain history, diagnostic electrocardiographic changes, and serial increase of cardiac biomarkers. All patients with inclusion/exclusion criteria satisfied and who will agree to sign the informed consent will be enrolled into the trial. The REMEDIAL IV trial will be conducted at a pool of Italian interventional cardiology centers, according to the principles of the Declaration of Helsinki and Good Clinical Practice and has been approved by the local Ethic Committees.
All the patients included into the study 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, as defined below. The patients will be then randomized into 2 groups: 1) DyeVert group, and 2) Control group.
STUDY ENDPOINTS The primary endpoint of the trial is the rate of CI-AKI. CI-AKI is defined as an increase in the serum creatinine (sCr) concentration ≥ 0.3 mg/dL from the baseline value within 5 days after CM administration or the need for dialysis. Secondary end-points will include: 1) differences in the CM volume in the 2 groups; 2) an increase in the sCr concentration ≥25% within 5 days after CM exposure; 4) the severity of AKI assessed according to the Acute Kidney Injury Network criteria: Stage 1, a sCr increase ≥0.3 mg/dL or ≥1.5-1.9 times from baseline; Stage 2, a sCr increase ≥2.0-2.9 times from baseline; and Stage 3, a sCr increase ≥3.0 times from baseline or the need for dialysis; 5) changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure; 6) the rate of acute renal failure requiring dialysis (defined as a decrease in renal function necessitating acute hemodialysis, ultrafiltration or peritoneal dialysis within the first 5 days post-intervention); 7) the rate of in-hospital, 6 and 12-month major adverse events (MAE), including death, renal failure requiring dialysis, acute pulmonary edema, and sustained kidney injury. Sustained kidney injury is defined as a persistent ≥25% GFR reduction compared to baseline at 6 and 12 months; and 8) the length in in-hospital stay, calculated as the sum of the number of days since admission until discharge from the hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
DyeVert group: injection will be handled by the DyeVert system. Control group: injection will be carried out by manual injection syringe. Patients don't know the arm in which they are assigned.
Study Groups
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DyeVert 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.
Coronary angiography using DyeVert system
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.
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 carried out by a conventional manual injection syringe. Strategies for limiting CM volume are:
1. 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;
2. catheters with sideholes will be strictly avoided during percutaneous intervention;
3. 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)
4. ''tests'' with ''puffs'' of CM are discouraged.
Coronary angiography using conventional manual injection syringe.
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.
Interventions
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Coronary angiography using DyeVert system
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.
Coronary angiography using conventional manual injection syringe.
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.
Eligibility Criteria
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Inclusion Criteria
ST-Elevation Myocardial Infarction (according to Fourth Universal Definition of Myocardial Infarction);
High-risk Non-ST-Elevation Myocardial Infarction (according to current guidelines):
1. Refractory angina,
2. Signs or symptoms of heart faiklure or new or worsening mitral regurgitation,
3. Hemodynamic instability,
4. Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy,
5. Sustained ventricular tachycardia or ventricular fibrillation,
6. Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Clinica Mediterranea
OTHER
Responsible Party
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Locations
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IRCCS Policlinico Multimedica
Milan, , Italy
Clinica Mediterranea
Naples, , Italy
Countries
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References
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Other Identifiers
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NCT006
Identifier Type: -
Identifier Source: org_study_id
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