A Contemporary Simple Risk Score for Prediction of Contrast-Associated Acute Kidney Injury After Percutaneous Coronary Intervention Development and Initial Validation
Sponsor study identifier
observational
14,616
1 country
1
Study Start
January 1, 2012
Actual (reported)Primary Completion
January 2, 2021
Actual (reported)Study Completion
September 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2012
Actual (reported)January 2, 2021
Actual (reported)September 1, 2021
Actual (reported)November 10, 2021
Actual (reported)November 24, 2021
Actual (reported)Rate of patients developing Contrast-Associated Acute Kidney Injury
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
Rate of all-cause death
1 year after PCI
Occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition
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.
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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).
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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.
Roxana Mehran, MD
Icahn School of Medicine at Mount Sinai
14,616 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2021
First Posted
November 24, 2021
Study Start
January 1, 2012
Actual (reported)Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction
Contact the study team to confirm eligibility.
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.
Primary Completion
January 2, 2021
Actual (reported)Study Completion
September 1, 2021
Actual (reported)Last Updated
November 24, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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