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

NCT ID: NCT04928092

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-03-31

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.

Conditions

Acute Kidney Injury; Coronary Artery Disease; Percutaneous Coronary Intervention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active research group

Patients undergoing intravascular imaging guided, low contrast PCI procedure as part of standard care

Standard of care Ultra Low Contrast PCI

Intervention Type: PROCEDURE

PCI using low amounts of contrast media which is standard of care at VCU Medical Center

Interventions

Standard of care Ultra Low Contrast PCI

PCI using low amounts of contrast media which is standard of care at VCU Medical Center

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Azzalini, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20019541

Identifier Type: -

Identifier Source: org_study_id