Ultra-Low Contrast Angiography in AKI

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: Acute Kidney Injury
• Intervention / Treatment: Procedure: Angiography

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

• Study Contact: Name: Zach Rozenbaum, MD; Phone Number: 504-988-5493; Email: zrozenbaum@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University Medical Center
      • Principal Investigator: Zach Rozenbaum, MD
      • Contact: Zach Rozenbaum, MD; Phone Number: 504-988-5493; Email: zrozenbaum@tulane.edu
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center
      • Principal Investigator: Zach Rozenbaum, MD
      • Contact: Zach Rozenbaum, MD; Phone Number: 504-988-5493; Email: zrozenbaum@tulane.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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	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	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

• Sponsor: Tulane University
• Investigators: Principal Investigator: Zach Rozenbaum, MD, Tulane University

Study record dates

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: Coronary angiography; Ultra low contrast
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques, Neurological; Radiography; Angiography; Neuroradiography; Neuroimaging; Cerebral Angiography
• 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