Using the DyeVert Plus system to reduce contrast-related kidney injury during coronary angiography and PCI
Official title: 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
Run by CAMC Health System · NCT04279457 · Data updated 2026-11-12
This study will test whether adding the DyeVert Plus device to standard hydration lowers the chance of contrast-induced kidney injury in adults with reduced kidney function having coronary angiography or PCI.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 1802 (estimated) |
| Sponsor | CAMC Health System Academic / other |
| Locations | 1 site (Charleston, West Virginia) |
| Status | Recruiting |
| Started | February 3, 2020 |
| Main results expected | January 1, 2022 |
| Study ends | February 3, 2022 |
| Registry record updated | February 24, 2020 |
| Trial ID | NCT04279457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–90 scheduled for coronary angiography or PCI with baseline eGFR 20–60 mL/min/1.73 m2 and serum creatinine >1.5 mg/dL, often with hypertension or diabetes, are eligible.
✕Probably not a fit
Patients with normal kidney function (eGFR >60 or creatinine <1.5 mg/dL), those on dialysis, pregnant people, or those with a dye allergy are unlikely to receive benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective Phase 4 interventional study enrolls adults with reduced kidney function (eGFR 20–60 mL/min/1.73 m2 and serum creatinine >1.5 mg/dL) who are scheduled for coronary angiography or PCI. All participants will receive a standardized hydration protocol and the DyeVert Plus system will be used during the procedure to minimize contrast volume. Investigators will monitor serum creatinine and eGFR after the procedure to determine the incidence of contrast-induced nephropathy. The trial aims to compare post-procedure acute kidney injury rates in this high-risk population when contrast volume is actively reduced.
Why it matters
Potential benefit: If successful, using the DyeVert Plus system with hydration could reduce the rate of contrast-induced kidney injury, lowering complications and shortening hospital stays for high-risk patients.
How similar studies have gone: Previous device studies have shown that contrast-reduction systems like DyeVert can reduce contrast volume and have sometimes lowered CIN rates, but results have been variable across studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria: 1. 18 years of age or older 2. Scheduled to undergo CAG and/or PCI 3. Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2 4. Serum creatinine \> 1.5mg/dl 5. Obtaining a Cardiac catheterization. 6. HTN/Diabetes 7. Inpatient and outpatient Exclusion Criteria: * Exclusion criteria: 1. 91 years of age or older 2. Serum creatinine \< 1.5mg/dl 3. eGFR \> 60ml/min 4. Pregnancy 5. Dialysis 6. Dye Allergy
Where it's running
-
CAMC Health Education and Research Institute
Charleston, West Virginia, United States Recruiting
Study contacts
- Study coordinator: Frank H Annie, PhD
- Email: frank.h.annie@camc.org
- Phone: 304-388-9921
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.