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

Acute Kidney Injury Clinical Trial

— NORDICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02263820
• Other study ID #: HSDX-1502
• Status: Completed
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: HealthSpan Dx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Diseases
• Renal Insufficiency
• Wounds and Injuries

Locations

Country	Name	City	State
United States	UNC Center for Heart & Vascular Care	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
HealthSpan Dx	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum creatinine levels (absolute and percentage)		Measured 48-72h after catheterization
Secondary	Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)		Within 90 days after catheterization
Secondary	Admission to the ICU		Within 90 days after catheterization