Proenkephalin for Prediction of Contrast-Associated Kidney Events

Coronary Artery Disease Clinical Trial

— PANCAKE  

Official title:

Proenkephalin ANd Creatinine in the Prediction of Cardiac Contrast-Associated Kidney Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989505
• Other study ID #: PANCAKE
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization. Recently, proenkephalin (penKid) was introduced as a new glomerular filtration marker. The aim of this study is to investigate whether the change in penKid level allows for early detection of affected patients.

Description:

Use of contrast media is necessary for diagnostic imaging and percutaneous coronary intervention. However, contrast-induced kidney injury, a complication of contrast use, has been identified as the most frequent cause of hospital-acquired acute kidney injury and is associated with poor prognosis. Currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization or on the following day, when the majority of patients who undergo elective cardiac catheterization are discharged from the hospital in the real-world setting. Recently, proenkephalin (penKid) was introduced as a new glomerular filtration marker, which is capable of identifying normal subjects at high risk of future decline in renal function. The aim of this study is to investigate whether the change in penKid level on the day following cardiac catheterization can predict kidney injury before hospital discharge and thus allows for early detection of affected patients.

For this purpose a total of 214 consecutive patients who undergo routine cardiac catherization will be recruited, and blood will be drawn at three time-points: immediately before catherization, 12-24 hours after catheterization and 4-8 weeks after discharge. Creatinine will be measured for endpoint definition, while the markers urea, CRP (C-reactive protein), NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury marker-1), cystatin C, suPAR (soluble urokinase-type plasminogen activator receptor), and penKid will be measured as biomarkers of interest. The main outcome measure is sustained kidney injury (SKI), which is defined as an increase above 20% in serum creatinine between time-points 1 and 3. The main test is whether the change in biomarkers between baseline and immediately before discharge (time-points 1 and 2) can predict the development of sustained kidney injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years of age

• Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media

• Ability to provide informed consent

Exclusion Criteria:

• Current use of renal replacement therapy/hemodialysis

• life expectancy < 6 months

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Nephropathy
• Coronary Artery Disease

Intervention

Diagnostic Test:
• blood-draw for biomarker analyses
Blood will be drawn at three time-points: immediately before catherization, 12-24 hours after catheterization and 4-8 weeks after discharge. Creatinine will be measured for endpoint definition, while the markers urea, CRP (C-reactive protein), NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury marker-1), cystatin C, suPAR (soluble urokinase-type plasminogen activator receptor), and penKid will be measured as biomarkers of interest.

Locations

Country	Name	City	State
Germany	University Heart Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. med. Mahir Karakas

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained kidney injury	defined as an increase above 20% in serum creatinine	Time period between the two time-points: immediately before catherization and 4-8 weeks after discharge