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

NCT05132062 | Completed

• 1 other identifier: IF2740658
• Study Type: observational
• Target: 14,616
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of all-cause death

  1 year after PCI

Study Arms (2)

Patients with CA-AKI occurrence

Occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition

Procedure: Percutaneous Coronary Intervention

Patients without CA-AKI occurrence

No occurrence of CA-AKI as defined by the Acute Kidney Injury Network definition

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

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 with CA-AKI occurrence; Patients without CA-AKI occurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

• 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.

  PMID: 32181730 BACKGROUND

• 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.

  PMID: 22267241 BACKGROUND

• 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.

  PMID: 28213620 BACKGROUND

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Roxana Mehran, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 24, 2021
• Study Start: January 1, 2012
• Primary Completion: January 2, 2021
• Study Completion: September 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

US (1)