Clinical trial NCT04928092: A Zero Acute Kidney Injury Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Official title: A Zero Acute Kidney Injury (Zero-AKI) Strategy for Percutaneous Coronary Intervention in Patients With ChronicKidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Kidney Injury
Coronary Artery Disease
Percutaneous Coronary Intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2021-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo a PCI.

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.

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

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: Up to 72 hours after the procedure
Secondary outcomes:
Other outcomes:
measure: Cardiac death
timeFrame: Up to 30 days after PCI procedure
measure: Myocardial infarction
timeFrame: Up to 30 days after PCI procedure
measure: Target lesion revascularization
timeFrame: Up to 30 days after PCI procedure
measure: All-cause mortality
timeFrame: Up to 30 days after PCI procedure
measure: Pericardial effusion
timeFrame: Up to 30 days after PCI procedure
measure: new need for dialysis
timeFrame: Up to 30 days after PCI procedure
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Lorenzo Azzalini, MD
role: PRINCIPAL_INVESTIGATOR
References: