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

NCT05132062 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14616

Last updated 2021-11-24

No results posted yet for this study

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.

Conditions

  • Contrast-induced Nephropathy

Interventions

PROCEDURE

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention is a catheter based technique widely used to restore coronary vessel patency. It is performed by fluoroscopic guidance and it requires the use of iodinated contrast medium. The use of iodinated contrast media has been historically linked to AKI occurring within days after their administration and typically referred to as CA-AKI. Furthermore, CA-AKI has been associated with long-term impairment of kidney function, need for renal replacement therapy, and subsequent all-cause mortality.

Sponsors & Collaborators

Principal Investigators

  • Roxana Mehran, MD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2021-01-02
Completion
2021-09-01

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05132062 on ClinicalTrials.gov