Low-Contrast Angiography for Acute Kidney Injury

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of using ultra-low contrast dye in heart imaging for individuals with acute kidney injury (AKI). It compares the immediate use of this imaging method to a delayed approach to determine which is better for kidney health. Potential participants include hospitalized individuals with AKI who require heart imaging. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in heart imaging safety.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that ultra-low contrast angiography is safe for patients with acute kidney injury?

Research has shown that using very little contrast dye in heart imaging is generally safe for people with existing kidney problems. Studies have found that using less dye (the liquid doctors use to see blood vessels) can help prevent further kidney damage, which is crucial for those with existing kidney issues.

Available data suggest that this method is well-tolerated. People who have undergone this procedure have not reported any unusual or serious side effects from the low amount of dye used. The goal is to reduce the risk of further kidney problems while assessing the heart.

These findings are encouraging for those considering joining a trial for this treatment, as they suggest a safer way to evaluate heart conditions in patients with kidney concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about ultra-low contrast angiography for acute kidney injury because it offers a potentially safer alternative to traditional contrast methods. Standard procedures often use higher doses of contrast agents, which can stress the kidneys, especially in patients with compromised renal function. This new approach utilizes significantly less contrast, reducing the risk of further kidney damage. By minimizing contrast exposure, the technique aims to safely provide critical diagnostic information without compromising kidney health.

What evidence suggests that ultra-low contrast angiography is effective for acute kidney injury?

This trial will compare immediate and delayed angiography interventions for individuals with acute kidney injury. Research has shown that using minimal contrast dye in heart imaging is safe for people with sudden kidney problems. This method is crucial because excessive dye can harm the kidneys. Studies indicate that using less dye reduces the risk of further kidney damage during these procedures. It is particularly beneficial for those with existing kidney issues or dye allergies. Overall, early evidence suggests it might be a safer option for individuals with kidney concerns requiring heart imaging. ^{1 2 3 4 6}

Who Is on the Research Team?

Zach Rozenbaum, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11129322/

Safety of ultra‐low contrast coronary angiography in ...

The current data suggest that ultra‐low contrast coronary angiography can be safely performed in patients with pre‐existing AKI The study should ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38801137/

Safety of ultra-low contrast coronary angiography in ...

The current data suggest that ultra-low contrast coronary angiography can be safely performed in patients with pre-existing AKI.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1936879824018569

Ultra-Low-Contrast PCI: A Structured Approach to ...

In addition to decreasing the probability of acute kidney injury during PCI, limiting the volume of iodinated contrast allows the operator to ...

4.

jacc.org

jacc.org/doi/10.1016/j.jacc.2024.09.379

TCT-325 Safety and Efficacy of Ultra-Low or Zero-Contrast ...

ULC and ZC PCI appear to be safe and effective. These techniques may be beneficial to patients with advanced kidney disease, contrast anaphylaxis, and ...

5.

jacc.org

jacc.org/doi/10.1016/j.jacc.2020.01.023

Contrast-Associated Acute Kidney Injury and Serious ...

Contrast-associated acute kidney injury (CA-AKI) associates with an increased relative risk for serious adverse outcomes.

6.

frontiersin.org

frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1073072/full

Contrast-induced acute kidney injury and its contemporary ...

This review presents an in-depth discussion of CI-AKI incidence, pathogenesis, risk prediction, current preventive strategies, and novel treatment ...