Proenkephalin for Prediction of Contrast-Associated Kidney Events

NCT03989505 | Completed

• 1 other identifier: PANCAKE
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

CIN; Coronary Angiography; Contrast; Angiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

blood-draw for biomarker analyses DIAGNOSTIC_TEST

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.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \> 18 years of age
• Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media
• Ability to provide informed consent

You may not qualify if:

• Current use of renal replacement therapy/hemodialysis
• life expectancy \< 6 months

Sponsors & Collaborators

• Dr. med. Mahir Karakas: lead

Study Sites (1)

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

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

MeSH Terms

Conditions

Acute Kidney Injury; Coronary Artery Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mahir Karakas, MD

  University Heart Center Hamburg

  PRINCIPAL INVESTIGATOR

• Johannes F Geng, MD

  University Heart Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2021
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

DE (1)