Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA)

August 15, 2018 updated by: Sapere Bio

Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)

Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.

The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.

The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Center for Heart & Vascular Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)

Description

Inclusion Criteria:

  • Adult patients (>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.
  • Medically compliant and able to consent and follow detailed directions
  • Agree to additional collection of blood sample 48-72h post cardiac catheterization

Exclusion Criteria:

  • Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).
  • Contrast media exposure within last 48h
  • Presenting with systolic time-segment elevation myocardial infarction.
  • Presence of cardiogenic shock
  • Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump
  • Severe kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2 or receiving dialysis for end stage renal disease
  • Kidney transplant and liver transplant patients and all patients currently on immunosuppressants
  • Severe heart failure with known ejection fraction <25%
  • Prior heart transplant
  • Chronic liver disease /cirrhosis
  • Patients actively undergoing chemotherapy or radiation treatment for any indication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in serum creatinine levels (absolute and percentage)
Time Frame: Measured 48-72h after catheterization
Measured 48-72h after catheterization

Secondary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)
Time Frame: Within 90 days after catheterization
Within 90 days after catheterization
Admission to the ICU
Time Frame: Within 90 days after catheterization
Within 90 days after catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sapere Bio

Collaborators

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: George A Stouffer, MD, University of North Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 10, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSDX-1502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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