Mehran 2.0 Risk Score for Prediction of CA-AKI After PCI

Completed

• Conditions: Contrast-induced Nephropathy
• Interventions: Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT05132062
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Consecutive patients having percutaneous coronary intervention (PCI) over a period of 9 years at a large tertiary care center with available creatinine measurements both before and within 48 hours after the procedure were included; patients on chronic dialysis were excluded. Patients treated between 2012 and 2017 comprised the derivation cohort (n=14,616) and those treated from 2018 to 2020 formed the validation cohort (n=5,606). The primary endpoint is contrast-associated acute kidney injury (CA-AKI, defined per Acute Kidney Injury Network \[AKIN\]). In addition, independent predictors of CA-AKI will be derived from multivariate logistic regression analysis. Model 1 will include only preprocedural variables, while Model 2 will also include procedural variables. A weighted integer score based on the effect estimate of each independent variable will be used to calculate the final risk score for each patient. Impact on 1-year mortality will be also evaluated.

Detailed Description

Consecutive patients who underwent PCI at a tertiary hospital (Mount Sinai Hospital, New York, NY, USA) between 2012 and 2020 with documented serum creatinine both pre- procedure and within 48 hours after PCI were identified from our existing prospectively populated database. Only patients who expired within 48 hours after PCI and with pre-existing end-stage renal disease requiring dialysis were excluded from the present analysis. CA-AKI was defined according to the Acute Kidney Injury Network as an increase by ≥50% or ≥0.3mg/dl within 48 hours after PCI compared to pre-PCI serum creatinine. Anemia was defined as hemoglobin plasma level ≤13 g/dl for men and ≤12 g/dl for women. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate (eGFR) of ≤60 ml/min/1.73 m2, per the Chronic Kidney Disease-Epidemiologic (CKD-EPI) formula. A dedicated data coordinating center performed all data management. Prespecified clinical and laboratory demographic information was obtained from hospital charts that were reviewed by independent research personnel who were unaware of the objectives of the study; accumulated data were then entered prospectively in the database. Patients treated between 2012 and 2017 will comprise the derivation cohort (n=14,616) and those treated from 2018 to 2020 will form the validation cohort (n=5,606). Independent predictors of CA-AKI (defined per Acute Kidney Injury Network) will be derived from multivariate logistic regression analysis. Model 1 will include only preprocedural variables, while Model 2 will also include procedural variables. A weighted integer score based on the effect estimate of each independent variable will be used to calculate the final risk score for each patient. Impact on 1-year mortality of CA-AKI occurrence will be also evaluated with Cox regression analysis. Multivariable Cox regression analysis will be also performed to look for independent association of CA-AKI occurrence with mortality.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2021-01-02
• Study Completion: 2021-09-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-11
• Last Update Submitted: 2021-11-11
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14616

Inclusion Criteria

• patients undergoing PCI
• patients with documented serum creatinine both pre- procedure and within 48 hours after PCI

Exclusion Criteria

• patients who expired within 48 hours after PCI
• patients with pre-existing end-stage renal disease requiring dialysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CA-AKI occurrence	Percutaneous Coronary Intervention	Occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition
Patients without CA-AKI occurrence	Percutaneous Coronary Intervention	No occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition

Primary Outcome Measures

Name	Time	Method
Rate of patients developing Contrast-Associated Acute Kidney Injury	48 hours after PCI	Contrast-Associated Acute Kidney Injury was defined according to the AKIN as an increase by ≥50% or ≥0.3mg/dl within 48 hours after PCI compared to pre-PCI serum creatinine

Secondary Outcome Measures

Name	Time	Method
Rate of all-cause death	1 year after PCI	Death from all-cause

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States