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

NCT04928092 | Withdrawn

• 1 other identifier: HM20019541
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cardiac death

  Up to 30 days after PCI procedure

• Myocardial infarction

  Up to 30 days after PCI procedure

• Target lesion revascularization

  Up to 30 days after PCI procedure

Study Arms (1)

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

Interventions

Standard of care Ultra Low Contrast PCI PROCEDURE

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

Active research group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo a PCI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Guerbet: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lorenzo Azzalini, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 16, 2021
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)