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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02263820
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : August 17, 2018
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Sapere Bio

Brief Summary:

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.

Condition or disease
Acute Kidney Injury Renal Insufficiency Kidney Diseases

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Study Type : Observational
Actual Enrollment : 185 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)
Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Primary Outcome Measures :
  1. Changes in serum creatinine levels (absolute and percentage) [ Time Frame: Measured 48-72h after catheterization ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Urine, plasma, buffy coat

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02263820

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United States, North Carolina
UNC Center for Heart & Vascular Care
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Sapere Bio
University of North Carolina, Chapel Hill
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Principal Investigator: George A Stouffer, MD University of North Carolina
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Responsible Party: Sapere Bio Identifier: NCT02263820    
Other Study ID Numbers: HSDX-1502
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Keywords provided by Sapere Bio:
Acute Kidney Injury
Acute Renal Failure
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Wounds and Injuries
Urologic Diseases