Ultra-Low Contrast Angiography in AKI

May 13, 2026 updated by: Tulane University

Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. 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.

Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University Medical Center
        • Principal Investigator:
          • Zach Rozenbaum, MD
        • Contact:
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center
        • Principal Investigator:
          • Zach Rozenbaum, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate intervention arm
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.
Procedure: Angiography
Coronary angiography with less than 20cc of contrast materials
Placebo Comparator: Delayed intervention arm
Delayed angiography will be performed after kidney function stabilizes.
Procedure: Angiography
Coronary angiography with less than 20cc of contrast materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in incidence of Contrast Induced Nephropathy (CIN)
Time Frame: Within 7 days
CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.
Within 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of earlier occurrence of CIN
Time Frame: Within 7 days
The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other
Within 7 days
Incidence of renal replacement therapy at up to 7 days post-angiography
Time Frame: Within 7 days
The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography
Within 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Investigators

  • Principal Investigator: Zach Rozenbaum, MD, Tulane University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-874

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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