DyeVert System and Contrast-induced Acute Kidney Injury

NCT04714736 | Completed DMC FDA Device

• 1 other identifier: NCT006
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the REnal Insufficiency Following Contrast MEDIA Administration TriaL IV (REMEDIAL IV) is to test whether the use of the DyeVert system is effective in reducing CI-AKI rate in ACS patients undergoing urgent/immediate (within 2 hours) invasive diagnostic and/or interventional cardiovascular procedures. The DyeVert™ system (Osprey Medical Inc., Minnetonka, MN, USA) is a novel device designed to reduce CM volume during coronary procedures, while maintaining fluoroscopic image quality. 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).

Conditions

Contrast-induced Acute Kidney Injury; Acute Coronary Syndromes

Keywords

acute kidney injury; Device: DyeVert™ system; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Rate of contrast-induced Acute Kidney Injury (CI-AKI).

  Serum creatinine (mg(dL) is assessed at baseline (before coronary intervention) and then every day during the hospital stay. CI-AKI is defined as a change in the serum creatinine concentration ≥0.3 mg/dL from the baseline value within 5 days after contrast media administration or the need for dialysis.

  30 days

Secondary Outcomes (7)

• Differences in the contrast media volume in the 2 groups.

  30 days

• Change in the sCr concentration ≥ 25 percent within 5 days after CM exposure.

  30 days

• Severity of AKI assessed according to the Acute Kidney Injury Network criteria.

  30 days

• Changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure.

  48 hours

• Rate of acute renal failure requiring dialysis.

  5 days

Study Arms (2)

DyeVert group

ACTIVE COMPARATOR

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.

Device: Coronary angiography using DyeVert system

Control group

SHAM COMPARATOR

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.

Procedure: Coronary angiography using conventional manual injection syringe.

Interventions

Coronary angiography using DyeVert system DEVICE

Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.

DyeVert group

Coronary angiography using conventional manual injection syringe. PROCEDURE

Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Mediterranea: lead

Study Sites (2)

IRCCS Policlinico Multimedica

Milan, 20142, Italy

Location

Clinica Mediterranea

Naples, 80121, Italy

Location

Related Publications (33)

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MeSH Terms

Conditions

Acute Coronary Syndrome; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be then randomized into 2 groups: 1) DyeVert group, and 2) Control group. 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients included into the study will be treated according to the following strategy. 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, as defined below. The patients will be then randomized into two groups: 1) DyeVert group, and 2) Control group.

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 19, 2021
• Study Start: February 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

IT (2)