A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease

Study Overview
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Brief Summary
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The purpose of this study is to compare the outcomes of Percutaneous Coronary Intervention (PCI) in patients with chronic kidney disease (CKD) using smaller doses of contrast dye that are validated as being at low risk of causing injury to the kidneys, with the larger doses that are traditionally used contemporary practice.

Detailed Description
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This study will evaluate whether using lower doses of contrast dye leads to lower rates of kidney injury compared to current standard of care. In particular, effort will be taken to maintain the total amount of contrast dye below a scientifically-validated threshold calculated on the basis of each participant renal function. Participants will already be scheduled to undergo a PCI. Because a smaller amount of contrast dye will be used, an intravascular ultrasound (IVUS) will be used to help the doctors see and open the blockages in participant's coronary arteries. IVUS is already used to optimize PCI results, but will be used more extensively in this case. The amount of contrast dye received will be tailored on each participant kidney function. Prospectively enrolled patients will be matched with historical controls who underwent PCI with non-intravascular imaging based approach.

Official Title
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A Zero Acute Kidney Injury (Zero-AKI) Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease

Conditions
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Acute Kidney Injury, Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Standard of care Ultra Low Contrast PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients undergoing elective and urgent (i.e., non-emergent) PCI Age >18 years eGFR <60 ml/min/1.73 m2 Angina or equivalent and/or documentation of inducible myocardial ischemia Presence of =1 coronary stenosis, evaluated >70% by visual estimation (on a previously performed coronary angiography) or with an FFR =0.80 ability to provide written informed consent Exclusion Criteria: Emergent PCI due to either hemodynamic instability, ST-elevation myocardial infarction or sudden cardiac death PCI on chronic total occlusion Prior PCI within 3 weeks Age >90 years Left ventricular ejection fraction <20% Need for mechanical circulatory support Pregnancy Prisoners Non-English speaking patients Inability to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active research group<br>Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care | Procedure: Standard of care Ultra Low Contrast PCI<br>* PCI using low amounts of contrast media which is standard of care at VCU Medical Center<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) | Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI | Up to 72 hours after the procedure |