Low-Contrast Angiography for Acute Kidney Injury

Overseen By Zach Rozenbaum, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Tulane University

Disqualifiers: Stabilized renal function, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

Research Team

Zach Rozenbaum, MD

Principal Investigator

Tulane University

Eligibility Criteria

This trial is for hospitalized patients who have acute kidney injury (AKI) either at the time of admission or develop it during their stay and need a heart blood vessel check called invasive coronary angiography. It's not for those with stable kidney function, contraindications other than AKI, urgent heart procedures that can't wait a week, planned or current dialysis around the procedure time, recent contrast media use, pregnant women, prisoners, under 18s or those unable to consent.

Inclusion Criteria

I was admitted to the hospital with AKI or developed it during my stay and need a heart artery exam.

Exclusion Criteria

My kidney function has been stable or improving in the last 24 hours.

I have not had contrast media for tests 7 days before or 6 days after my heart imaging test.

I need a heart procedure that can't wait a week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Immediate Intervention

Immediate angiography performed within 24 hours of enrollment with serum creatinine monitoring

1 week

Multiple visits for serum creatinine collection

Delayed Intervention

Delayed angiography performed after kidney function stabilizes with serum creatinine monitoring

1 week

Multiple visits for serum creatinine collection

Follow-up

Participants are monitored for safety and effectiveness after angiography

1 week

Serum creatinine measured at 24h, 48h, and 1 week post-angiography

Treatment Details

Interventions

• Ultra-Low Contrast Angiography

Trial Overview The study tests the safety of using an ultra-low amount of dye in coronary angiography—a procedure to visualize heart vessels—in patients with acute kidney injury. The goal is to see if this method reduces further harm to kidneys while still providing clear images for diagnosis.

Participant Groups

Group I: Immediate intervention arm Active Control 1 Intervention

Immediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.

Group II: Delayed intervention arm Placebo Group 1 Intervention

Delayed angiography will be performed after kidney function stabilizes.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+