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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease; Acute Kidney Injury; Percutaneous Coronary Intervention
• Intervention / Treatment: Procedure: Standard of care Ultra Low Contrast PCI

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo a PCI.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active research group; Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care	Procedure: Standard of care Ultra Low Contrast PCI; PCI using low amounts of contrast media which is standard of care at VCU Medical Center

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Number of cardiac deaths	Up to 30 days after PCI procedure
Myocardial infarction	Number of myocardial infarctions	Up to 30 days after PCI procedure
Target lesion revascularization	Number of target-lesion revascularizations	Up to 30 days after PCI procedure
All-cause mortality	Number of deaths due to any cause	Up to 30 days after PCI procedure
Pericardial effusion	Number of pericardial effusion	Up to 30 days after PCI procedure
new need for dialysis	Number of new patients needing dialysis	Up to 30 days after PCI procedure

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Guerbet

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Coronary Disease; Coronary Artery Disease; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: HM20019541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No