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Citation
Myles, John (2023). Biomarker Collection and Analysis in the Prevention of Serious Adverse Events Following Angiography (PRESERVE) Trial Cohort (PRESERVE) (Version 1) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/z6wg-1649
Data Availability Statement
Data from the Biomarker Collection and Analysis in the Prevention of Serious Adverse Events Following Angiography (PRESERVE) Trial Cohort (PRESERVE) [(Version 1) https://doi.org/10.58020/z6wg-1649] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The PRESERVE study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the PRESERVE study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the PRESERVE study and does not necessarily reflect the opinions or views of the PRESERVE study, NIDDK-CR, or NIDDK.
Data Package Version
Version 1 (Updated on: Mar 03, 2023)
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General Description

The intravascular administration of iodinated contrast media for diagnostic imaging is a common cause of acute kidney injury (AKI) and a leading cause of iatrogenic renal disease. Contrast-induced AKI is associated with serious adverse outcomes including death, need for dialysis, prolonged hospitalization, and acceleration in the rate of progression of underlying chronic kidney disease. The benefit of IV isotonic bicarbonate compared to IV isotonic saline and of N-acetylcysteine for the prevention of contrast-induced AKI and associated adverse outcomes remains unclear. The purpose of the PRESERVE trial was to compare the effectiveness of IV isotonic sodium bicarbonate with IV isotonic sodium chloride and oral NAC with placebo for the prevention of serious adverse outcomes in high-risk participants scheduled to undergo coronary or non-coronary angiography.

The Biomarker Collection and Analysis sub-study collected, banked, and analyzed the blood and urine of participants from the VA-funded PRESERVE trial. Blood and urine proteins and other markers may predict the development of contrast-induced acute kidney injury and diagnose the very early stages of this condition following angiography. In addition, these biomarkers may predict which patients that develop acute kidney injury following angiography are likely to experience serious longer-term complications such as death, need for dialysis, and/or progressive loss of kidney function.

Primary Objectives

The aim of the Biomarker Collection and Analysis sub-study was to establish a biorepository of blood and urine samples from the PRESERVE trial participants to allow for future analyses of known and yet-to-be identified biomarkers that may predict and diagnose contrast-induced acute kidney injury.

Outcome Measure

The primary outcome included a composite of serious, adverse, patient-centered events, such as death, need for acute dialysis, and persistent decline in kidney function.

Inclusion Criteria

All sub-study participants were from the PRESERVE trial. Recruitment for the sub-study occurred when participants enrolled in the PRESERVE trial. No additional inclusion or exclusion criteria were applied for participation.

Outcome

Pre-angiography measurements of plasma biomarkers and urine biomarkers modestly predicted the development of major adverse kidney events and death. Measurement of these injury and repair biomarkers can be used to improve the efficiency of future contrast-associated acute kidney injury trials.

Research Area

Kidney Disease

Study Type

Observational

Study Sites

33

Condition

Cardiovascular Disorder, Acute Kidney Injury

Medication or Intervention Agent

Drug Therapy

Procedure

None

Keywords

Acute Kidney Injury (AKI), Urine Biomarkers, Plasma Biomarkers, Isotonic Bicarbonate, Undergo Coronary Angiography, Renal Disease

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases (KUH)

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Permitted Use(s) of the Resources
  • Use is allowed for any research purpose

  • Use does not allow specimens for genetic research purposes

Certificate of Confidentiality
  • This NIDDK-funded study is covered by a Certificate of Confidentiality. More information on what this means to Requestors is available in the NIH FAQ.

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Datasets (0)
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Specimens (18,489)
Specimens Table
Specimen
Count
Plasma5145
Serum6810
Urine6534