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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02263820

Acronym

NORDICA

Enrollment

185

Registered

2014-10-13

Start date

2015-01-31

Completion date

2016-12-31

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Kidney Diseases, Renal Insufficiency

Keywords

Acute Kidney Injury, Acute Renal Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results