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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)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
Publications
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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.

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.

Eligibility 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

Study Start Date

2013-10

Study End Date

2017-10

Condition

Cardiovascular Disorder, Acute Kidney Injury

Keywords

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

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

924
Participants

Target Population
Adults
Age statistics is not available for this study
Location statistics is not available for this study

Public Documents Table
Document Name
Description
Document Type
File Format
Compliance
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Datasets (35)
Datasets Table
Dataset Name
Description
# of Records
# of Variables
File Format(s)
Serious Adverse Event MedDRA Codes Dataset
Captures serious adverse event data, including MedDRA codes1000sas7bdat (1.42 MB); csv (152.01 KB)
Additional or Replacement Study Drug Assignment Dataset
Captures additional or replacement study drug data619sas7bdat (792 KB); csv (67.38 KB)
5 Days Post Procedure Dataset
Captures 5 days post procedure data5354sas7bdat (832 KB); csv (334.39 KB)
35 Days Post Procedure Dataset
Captures 35 days post procedure data904sas7bdat (192 KB); csv (63.44 KB)
Pre Procedure Laboratory Values Dataset
Captures data on pre procedure laboratory test values 924sas7bdat (320 KB); csv (163 KB)
Pre Procedure Non-Study Medications Dataset
Captures data on pre procedure non-study medications5845sas7bdat (768 KB); csv (249.46 KB)
Study IV Fluid Administration Dataset
Captures study IV fluid administrative data2332sas7bdat (512 KB); csv (161.84 KB)
Pre Procedure Non-Study IV Fluid Dataset
Captures pre procedure non-study IV fluid data924sas7bdat (640 KB); csv (185.88 KB)
Post Procedure Urine pH Results Datasets
Captures post procedure urine pH results data919sas7bdat (192 KB); csv (42.6 KB)
Early Participant Withdrawal Dataset
Captures data on early participant withdrawal41sas7bdat (128 KB); csv (4.14 KB)
Procedure Related Dataset
Contains procedure related data918sas7bdat (768 KB); csv (100.99 KB)
Adverse Event Dataset
Captures adverse event data103sas7bdat (1.23 MB); csv (41.93 KB)
Form 19 Adverse Event Dataset
Captures adverse event data from associated with Form 19219sas7bdat (128 KB); csv (19.1 KB)
90 Days Post Procedure Dataset
Captures 90 days post procedure data889sas7bdat (192 KB); csv (52.95 KB)
Local Lab US CON Dataset
Captures local lab data14sas7bdat (208 KB); csv (2.4 KB)
Study Blood Specimens Dataset
Captures study blood specimens data2654sas7bdat (576 KB); csv (181.86 KB)
CSP578 Serious Adverse Event Follow-Up Dataset
Captures serious adverse event follow-up data30sas7bdat (512 KB); csv (9.34 KB)
Central Lab Dataset
Captures central lab results data912sas7bdat (640 KB); csv (149.75 KB)
Sub Protocol Dataset
Captures sub protocol data954sas7bdat (4.75 MB); csv (192.79 KB)
CSP578 ITT Dataset
Captures CSP578 data924sas7bdat (448 KB); csv (180.86 KB)
Initial Study Drug Assignment Dataset
Captures initial study drug assignment data924sas7bdat (192 KB); csv (48.82 KB)
Endpoint Serious Adverse Event Dataset
Captures endpoint serious adverse event data associated with Form 201010sas7bdat (2.13 MB); csv (449.14 KB)
Protocol Deviation Dataset
Captures data on protocol deviation914sas7bdat (1.12 MB); csv (198.63 KB)
Local Lab US Dataset
Captures local lab data7sas7bdat (368 KB); csv (1.76 KB)
12 Hours Post Procedure Dataset
Captures 12 hours post procedure data1832sas7bdat (1.19 MB); csv (117.72 KB)
Adverse Event MedDRA Codes Dataset
Captures adverse event data, including MedDRA codes103sas7bdat (312 KB); csv (15.51 KB)
Blood Pressure and Weight Dataset
Captures blood pressure and weight data924sas7bdat (320 KB); csv (64.06 KB)
NIDDK DB Final Dataset
Final NIDDK dataset21381sas7bdat (14.31 MB); csv (2.91 MB)
Serious Adverse Event Dataset
Captures serious adverse event data1000sas7bdat (21.92 MB); csv (762.23 KB)
Local Lab US BL Dataset
Captures local lab data5sas7bdat (128 KB); csv (146 B)
Hospitalizations Within 96 Hours Post Procedure Dataset
Captures data on hospitalizations within 96 hours post procedure956sas7bdat (512 KB); csv (59.47 KB)
Demographics Dataset
Captures demographics data924sas7bdat (320 KB); csv (63.36 KB)
Medical History Dataset
Captures medical history data924sas7bdat (192 KB); csv (51.56 KB)
US Local Dataset
Captures US local data14sas7bdat (128 KB); csv (630 B)
CF 13 Dataset
Captures CF 13 data919sas7bdat (1.32 MB); csv (54.91 KB)
Specimens (18,489)
Specimens Table
Specimen
Count
Plasma5145
Serum6810
Urine6534