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

NCT ID: NCT02263820

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 185 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Sapere Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George A Stouffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

UNC Center for Heart & Vascular Care

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

HSDX-1502

Identifier Type: -

Identifier Source: org_study_id