Chronic Kidney Disease Clinical Trial
Official title:
Biomarker Effectiveness Analysis in Contrast Nephropathy
Verified date | October 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 922 |
Est. completion date | June 30, 2023 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Pittsburgh | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), US Department of Veterans Affairs |
Murugan R, Boudreaux-Kelly MY, Kellum JA, Palevsky PM, Weisbord S. Contrast-associated acute kidney injury and cardiovascular events: a secondary analysis of PRESERVE cohort. Clinical Kidney Journal. September 01, 2023 (ahead of print) https://doi.org/10.1093/ckj/sfad214
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 Pr — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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