Proenkephalin for Prediction of Contrast-Associated Kidney Events (PANCAKE)
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|ClinicalTrials.gov Identifier: NCT03989505|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2019
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment|
|Contrast-induced Nephropathy Acute Kidney Injury Coronary Artery Disease||Diagnostic Test: blood-draw for biomarker analyses|
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|
|Estimated Enrollment :||200 participants|
|Official Title:||Proenkephalin ANd Creatinine in the Prediction of Cardiac Contrast-Associated Kidney Events|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||July 2026|
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.
- Sustained kidney injury [ Time Frame: Time period between the two time-points: immediately before catherization and 4-8 weeks after discharge ]defined as an increase above 20% in serum creatinine
Biospecimen Retention: Samples With DNA
- A venous blood sample (10 ml EDTA, 10ml Serum) for storage and further analysis
- A venous blood sample (Buffy Coat) for DNA Analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989505
|University Heart Center Hamburg|
|Hamburg, Germany, 20246|
|Principal Investigator:||Mahir Karakas, MD||University Heart Center Hamburg|
|Principal Investigator:||Johannes F Geng, MD||University Heart Center Hamburg|