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

Withdrawn

• Conditions: Acute Kidney Injury; Percutaneous Coronary Intervention; Coronary Artery Disease

• Registration Number: NCT04928092
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Status Verified: 2022-01
• Study Start: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-04
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury (AKI)	Up to 72 hours after the procedure	Standard laboratory assays related to renal function will be used to identify which, if any, patients develop AKI

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States