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CompletedNCT02263820NORDICAUpdated Aug 17, 2018

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

An observational study in Acute Kidney Injury, Renal Insufficiency and Kidney Diseases, sponsored by Sapere Bio. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Sapere Bio · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
185
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Kidney Injury
  • Renal Insufficiency
  • Kidney Diseases

Keywords

  • Acute Kidney Injury
  • Acute Renal Failure
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 185 is close to the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Sapere Bio is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
185 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

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Study locations

1 site
  • UNC Center for Heart & Vascular Care
    Chapel Hill, North Carolina 27599, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02263820
Lead sponsor
Sapere Bio
Collaborators
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Oct 13, 2014
Start date
Jan 2015
Primary completion
Jul 2016
Completion
Dec 2016
Last update
Aug 17, 2018

Study contacts

George A Stouffer, MD
principal investigator · University of North Carolina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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