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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 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment
Contrast-induced Nephropathy Acute Kidney Injury Coronary Artery Disease 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

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.




Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
University Heart Center Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Dr. med. Mahir Karakas
Investigators
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Principal Investigator: Mahir Karakas, MD University Heart Center Hamburg
Principal Investigator: Johannes F Geng, MD University Heart Center Hamburg

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Responsible Party: Dr. med. Mahir Karakas, Coordinating Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03989505     History of Changes
Other Study ID Numbers: PANCAKE
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. med. Mahir Karakas, Universitätsklinikum Hamburg-Eppendorf:
CIN
Coronary Angiography
Contrast
Angiography
Additional relevant MeSH terms:
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Acute Kidney Injury
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency