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NCT Number: NCT05906758

Ultra-Low Contrast Angiography in 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tulane University Medical Center, New Orleans, Louisiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

angiography

Procedure

Coronary angiography with less than 20cc of contrast materials

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Zach Rozenbaum, MD

CONTACT

[email protected]

504-988-5493

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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