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

S

Sapere Bio

Status

Completed

Conditions

Kidney Diseases
Acute Kidney Injury
Renal Insufficiency

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT02263820
HSDX-1502

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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