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

Coronary Artery Disease Clinical Trial

— Zero-AKI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04928092
• Other study ID #: HM20019541
• Status: Withdrawn
• Start date: January 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Wounds and Injuries

Intervention

Procedure:
• Standard of care Ultra Low Contrast PCI
PCI using low amounts of contrast media which is standard of care at VCU Medical Center

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Guerbet

Country where clinical trial is conducted

United States, 

Outcome

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