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NCT Number: NCT02263820

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Center for Heart & Vascular Care

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes in serum creatinine levels (absolute and percentage)

    Time frame: Measured 48-72h after catheterization

Secondary outcomes

  1. Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)

    Time frame: Within 90 days after catheterization

  2. Admission to the ICU

    Time frame: Within 90 days after catheterization

Sponsors and collaborators

Lead sponsor

Sapere Bio

Industry

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: NORDICA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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