Ultra-Low Contrast Angiography in AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Angiography

Intervention Type PROCEDURE

Coronary angiography with less than 20cc of contrast materials

Delayed intervention arm

Delayed angiography will be performed after kidney function stabilizes.

Group Type PLACEBO_COMPARATOR

Angiography

Intervention Type PROCEDURE

Coronary angiography with less than 20cc of contrast materials

Interventions

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Angiography

Coronary angiography with less than 20cc of contrast materials

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No