Ultra-Low Contrast Angiography in AKI

Tulane University

Status and phase: Enrolling; Phase 3

Conditions: Acute Kidney Injury

Treatments: Procedure: Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05906758

2023-874

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups, including a placebo group

Immediate intervention arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Angiography

Delayed intervention arm

Placebo Comparator group

Description:

Delayed angiography will be performed after kidney function stabilizes.

Treatment:

Procedure: Angiography