Ultra-low contrast coronary angiography for patients with acute kidney injury
Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)
This study will test whether using very small amounts of contrast dye during coronary angiography is safe for hospitalized patients who have acute kidney injury.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 2 sites (New Orleans, Louisiana and 1 other locations) |
| Trial ID | NCT05906758 on ClinicalTrials.gov |
What this trial studies
This is an open-label, non-inferiority randomized controlled trial enrolling hospitalized adults with acute kidney injury who require invasive coronary angiography. Participants are randomized to immediate angiography (within 24 hours) or to delayed angiography after renal function stabilizes, with percutaneous coronary intervention deferred for 7 days if indicated. Ultra-low contrast techniques will be used during angiography, and serum creatinine will be measured at enrollment, within 6 hours before angiography, and at 24 hours, 48 hours, and 1 week afterward. Hydration and other peri-procedural care are managed by the treating team and the primary outcome compares kidney-related safety between the two timing strategies.
Who should consider this trial
Good fit: Hospitalized adults with acute kidney injury who need invasive coronary angiography, can give informed consent, and have no other contraindication to angiography are the intended participants.
Not a fit: People already on or scheduled for renal replacement therapy, pregnant patients, prisoners, cognitively impaired individuals, those under 18, or patients who cannot postpone indicated PCI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could allow safe earlier heart imaging for AKI patients while reducing the risk of further kidney injury from contrast dye.
How similar studies have performed: Small observational studies and procedural reports indicate ultra-low contrast angiography is feasible and can reduce contrast volume, but randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Exclusion Criteria: * Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment. * Contraindication for invasive coronary angiography other than AKI. * Percutaneous coronary intervention is indicated and cannot be postponed by 7 days. * Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography). * Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography. * Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.
Where this trial is running
New Orleans, Louisiana and 1 other locations
- Tulane University Medical Center — New Orleans, Louisiana, United States (Recruiting)
- University Medical Center — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Zach Rozenbaum, MD — Tulane University
- Study coordinator: Zach Rozenbaum, MD
- Email: zrozenbaum@tulane.edu
- Phone: 504-988-5493
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.