Clinical trial NCT02263820: Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography
Official title: Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography (NORDICA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Keywords: Acute Kidney Injury
Acute Renal Failure
Lead sponsor: Sapere Bio
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2014-10-13
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in serum creatinine levels (absolute and percentage)
timeFrame: Measured 48-72h after catheterization
Secondary outcomes:
measure: Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)
timeFrame: Within 90 days after catheterization
measure: Admission to the ICU
timeFrame: Within 90 days after catheterization
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Heart & Vascular Care
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: George A Stouffer, MD
role: PRINCIPAL_INVESTIGATOR
References: