Using the DyeVert Plus system to reduce contrast-related kidney injury during coronary angiography and PCI
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
PHASE4 · CAMC Health System · NCT04279457
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1802 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | CAMC Health System (other) |
| Locations | 1 site (Charleston, West Virginia) |
| Trial ID | NCT04279457 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Charleston, West Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AKI Due to Trauma