Biomarker Effectiveness Analysis in Contrast Nephropathy (BEACON)

NCT03004950 | Completed

• 2 other identifiers: PRO16090669R01DK106256-01A1
• Study Type: observational
• Target: 922
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is an observational non-interventional study which will examine a) the accuracy of biomarkers in predicting renal and cardiovascular outcomes after contrast-induced acute kidney injury. This study will obtain de-identified human plasma \& urine samples and corresponding de-identified research study data on subjects who are enrolled into the Prevention of Serious Adverse Events Following Angiography (PRESERVE) study and Biomarker Collection and Analysis in the PRESERVE Trial (VA CSP #578). Biomarker analyses will be performed on the de-identified samples and merged with de-identified research study data.

Conditions

Acute Renal Failure; Kidney Diseases; Chronic Kidney Disease; Coronary (Artery); Disease

Outcome Measures

Primary Outcomes (1)

• Predicting the composite renal outcome of death, dialysis dependence, or persistent renal injury, biomarker reclassification of risk for adverse renal outcomes and develop a risk score, and predicting the progression of chronic kidney disease

  Day 90 after contrast exposure

Secondary Outcomes (1)

• urinary biomarkers in predicting the composite outcome of hospitalization with acute coronary syndrome; heart failure; cerebrovascular accident; or all-cause mortality within 90 days,

  Within 90 days

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

1,100 men and women enrolled into the PRESERVE trial (NCT01467466)

You may qualify if:

• Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media in which it is anticipated that there will be an interval of ≥3 hours between the identification of the indication for angiography and the time of the planned procedure
• Pre-angiography eGFR \<60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR \<45 ml/min/1.73 m2 with or without diabetes mellitus
• Ability to provide informed consent

You may not qualify if:

• Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or slow low efficiency dialysis
• Stage 5 chronic kidney disease (eGFR \<15 mL/min/1.73 m2)
• Unstable baseline serum creatinine (if known) at the time of angiography defined by a change in serum creatinine of ≥25% over the 3 days prior to angiography
• Decompensated heart failure requiring any of the following therapies at the time of angiography
• Emergent angiography procedures defined as an anticipated duration of \<3 hours between the identification of the indication for angiography and the time of the planned procedure. We are excluding these patients due to the limited time to collect necessary research data and to ensure that research procedures do not interfere with clinical care
• Receipt of intravascular iodinated contrast within the 7 days preceding angiography
• Receipt of oral or IV NAC within the 48 hours preceding angiography
• Known allergy to NAC
• Known allergy to iodinated contrast media
• Age \<18 years
• Pregnancy
• Prisoner
• Ongoing participation in a concurrent interventional study
• Eligible patients who indicate at the time of recruitment an unwillingness to comply with the 96-hour and 90-day outcome assessments

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• US Department of Veterans Affairs: collaborator

Related Publications (2)

• Murugan R, Boudreaux-Kelly MY, Kellum JA, Palevsky PM, Weisbord S. Contrast-associated acute kidney injury and cardiovascular events: a secondary analysis of the PRESERVE cohort. Clin Kidney J. 2023 Sep 1;16(12):2626-2638. doi: 10.1093/ckj/sfad214. eCollection 2023 Dec.

  PMID: 38046040 BACKGROUND

• Murugan R, Boudreaux-Kelly MY, Kellum JA, Palevsky PM, Weisbord S; Biomarker Effectiveness Analysis in Contrast Nephropathy (BEACON) Study Investigators. Kidney Cell Cycle Arrest and Cardiac Biomarkers and Acute Kidney Injury Following Angiography: The Prevention of Serious Adverse Events Following Angiography (PRESERVE) Study. Kidney Med. 2022 Dec 21;5(3):100592. doi: 10.1016/j.xkme.2022.100592. eCollection 2023 Mar.

  PMID: 36874509 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Diseases; Renal Insufficiency, Chronic; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Raghavan Murugan, MD, MS, FRCP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: December 29, 2016
• Study Start: October 1, 2016
• Primary Completion: February 28, 2022
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share