Mehran 2.0 Risk Score for Prediction of CA-AKI After PCI
November 11, 2021 updated by: Roxana Mehran, Icahn School of Medicine at Mount Sinai
A Contemporary Simple Risk Score for Prediction of Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention Development and Initial Validation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
14616
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with coronary artery disease have rather high prevalence of comorbidities associated with increased risk of CA-AKI, and those undergoing PCI may also sustain acute hemodynamic disturbances that further raise the risk of CA-AKI.
All patients undergoing PCI at the Mount Sinai Hospital, New York, NY, have been screened for inclusion in the present analysis.
No limits were set for age, sex and comorbidities (except for end-stage renal disease requiring dyalisis).
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with CA-AKI occurrence
Occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition
|
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.
|
|
Patients without CA-AKI occurrence
No occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of patients developing Contrast-Associated Acute Kidney Injury
Time Frame: 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
|
48 hours after PCI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of all-cause death
Time Frame: 1 year after PCI
|
Death from all-cause
|
1 year after PCI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mettler FA Jr, Mahesh M, Bhargavan-Chatfield M, Chambers CE, Elee JG, Frush DP, Miller DL, Royal HD, Milano MT, Spelic DC, Ansari AJ, Bolch WE, Guebert GM, Sherrier RH, Smith JM, Vetter RJ. Patient Exposure from Radiologic and Nuclear Medicine Procedures in the United States: Procedure Volume and Effective Dose for the Period 2006-2016. Radiology. 2020 May;295(2):418-427. doi: 10.1148/radiol.2020192256. Epub 2020 Mar 17.
- Seeliger E, Sendeski M, Rihal CS, Persson PB. Contrast-induced kidney injury: mechanisms, risk factors, and prevention. Eur Heart J. 2012 Aug;33(16):2007-15. doi: 10.1093/eurheartj/ehr494. Epub 2012 Jan 19.
- McDonald JS, McDonald RJ, Williamson EE, Kallmes DF, Kashani K. Post-contrast acute kidney injury in intensive care unit patients: a propensity score-adjusted study. Intensive Care Med. 2017 Jun;43(6):774-784. doi: 10.1007/s00134-017-4699-y. Epub 2017 Feb 17. Erratum In: Intensive Care Med. 2017 Jun;43(6):956.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
January 2, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
November 10, 2021
First Submitted That Met QC Criteria
November 11, 2021
First Posted (Actual)
November 24, 2021
Study Record Updates
Last Update Posted (Actual)
November 24, 2021
Last Update Submitted That Met QC Criteria
November 11, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IF2740658
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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