Proenkephalin for Prediction of Contrast-Associated Kidney Events (PANCAKE)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Acute Kidney Injury; Contrast-induced Nephropathy
• Intervention / Treatment: Diagnostic test: blood-draw for biomarker analyses

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Heart Center Hamburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing coronary or non-coronary angiography with iodinated contrast media at the University Heart Center Hamburg

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cohort; 214 consecutive patients undergoing contrast-enhanced diagnostic and/ or therapeutical intervention in the cath lab of the University Heart Center Hamburg

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. med. Mahir Karakas
• Investigators: Principal Investigator: Mahir Karakas, MD, University Heart Center Hamburg; Principal Investigator: Johannes F Geng, MD, University Heart Center Hamburg

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: CIN; Angiography; Coronary Angiography; Contrast
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Coronary Disease; Coronary Artery Disease; Acute Kidney Injury
• Other Study ID Numbers: PANCAKE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No