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

NCT02263820 | Completed

• 1 other identifier: HSDX-1502
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases

Keywords

Acute Kidney Injury; Acute Renal Failure

Outcome Measures

Primary Outcomes (1)

• Changes in serum creatinine levels (absolute and percentage)

  Measured 48-72h after catheterization

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sapere Bio: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

UNC Center for Heart & Vascular Care

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine, plasma, buffy coat

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• George A Stouffer, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)