Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

Single-Center Prospective Study to Investigate the Difference in the Incidence of Contrast-Induced Nephropathy in High-Risk Patients With the Use of the Dye-Vert Plus System

Who is this study for? Patients with AKI (Acute Kidney Injury) Due to Trauma
Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Coronary angiography (CAG) for diagnostic or therapeutic purposes such as percutaneous coronary intervention (PCI) is one of the common procedures which require the use of intravenous contrast media. The reported incidence of contrast induced nephropathy (CIN) in high-risk patients following CAG varies from 10% to 30%. The high rate of CIN in post-PCI patients could be related either to the patient (advanced age, previous CKD, diabetes, dehydration, and concomitant use of other nephrotoxic drugs) or procedure related (intra-arterial route of administration, use of high osmolar contrast media, repeated exposure to contrast within 48 hours, volume of contrast used). Several strategies to prevent or treat CIN have been developed, including hydration, N-acetyl-cysteine, statins, ascorbic acid, bicarbonate, aminophylline, forced diuresis, renal replacement therapy, and choice of low-osmolarity or alternative agents, but one of the most obvious means is to minimize contrast volume. The DyeVert plus Contrast Reduction System, is designed to lower the amount of contrast dye the kidneys are exposed to during a procedure. Because the amount of contrast dye is precisely controlled. The purpose of this prospective study is to understand how the monitoring system of Dye-Vert Plus will impact Acute Kidney Injuries rates in high-risk patients undergoing cardiac catheterization when used in conjunction with a standardized hydration policy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ 18 years of age or older

• Scheduled to undergo CAG and/or PCI

• Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2

• Serum creatinine \> 1.5mg/dl

• Obtaining a Cardiac catheterization.

• HTN/Diabetes

• Inpatient and outpatient

Locations
United States
West Virginia
CAMC Health Education and Research Institute
RECRUITING
Charleston
Contact Information
Primary
Frank H Annie, PhD
frank.h.annie@camc.org
304-388-9921
Time Frame
Start Date: 2020-02-03
Estimated Completion Date: 2022-02-03
Participants
Target number of participants: 1802
Treatments
Active_comparator: Standardized Hydration protocol
These cases will follow Charleston Area Medical Centers standard Hydration protocol
Active_comparator: Hydration + Device
These cases will follow Charleston Area Medical Centers standard hydration protocol plus use the DyeVert Plus System
Sponsors
Leads: CAMC Health System

This content was sourced from clinicaltrials.gov

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