Copeptin and HFABP in Cardiac Surgery (PRACTICE)

Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study

In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Valvular Heart Disease
• Intervention / Treatment: Diagnostic test: Blood sampling

Detailed Description

The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day before surgery (day -1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. Blood will be sampled prior to induction (Troponin), upon arrival in the intensive care unit (Troponin, HFABP and Copeptin), and on postoperative day 1 and 2 (Troponin). Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.

All patients will be contacted after 30 days and 12 months by E-Mail, postal mail and/or phone call to obtain for the 12-item WHODAS 2 and information on potential events.

• Study Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Sebastian Roth, MD; Phone Number: +492118118451; Email: Sebastian.Roth@med.uni-duesseldorf.de
• Study Contact Backup: Name: Giovanna Lurati Buse, MD; Phone Number: +492118117828; Email: Giovanna.LuratiBuse@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Recruiting
      • Heinrich-Heine-Universität
      • Contact: Sebastian Roth, MD; Phone Number: +492118118451; Email: Sebastian.Roth@med.uni-duesseldorf.de
      • Contact: Giovanna Lurati Buse, MD; Phone Number: +492118117828; Email: Giovanna.LuratiBuse@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective on-pump cardiac surgery (i.e. CABG and/or valvular surgery).

Description

Inclusion Criteria:

• Adult (≥ 18 years of age)
• Elective surgery
• On-pump cardiac surgery (CABG and/or valvular surgery)

Exclusion Criteria:

• Heart transplantation (HTX)
• ACS at presentation (< 14 days)
• Emergency surgery
• Preoperative inotropic or mechanical circulatory support
• Left or right ventricular assist device implantation
• Unwilling or unable to provide consent
• Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Surgery; Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery)	Diagnostic test: Blood sampling; Blood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability-free survival	Disability is defined as a persistent (at least 6 months) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guidelines.	1 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and out of hospital	Patient-centered outcome to measure morbidity and mortality after surgery	At 30 days and 12 months after surgery
Major adverse cardiovascular events (MACE)	Defined as non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure or transfer to a higher unit of care, atrial fibrillation or stroke	At 30 days and 12 months after surgery
All cause mortality	Evaluate mortality after cardiac surgery	At 30 days and 12 months after surgery
Length of ICU-stay	To observe the length and/or readmission rate of intensive care unit stay	At 30 days
Acute kidney injury (AKI)	As defined by the three-stage KDIGO (Kidney Disease: Improving Global Outcome) classification of severity	At 30 days

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Data will be entered into a secure on-line database documenting the time and individual entering the data. Data will be collected directly from source documents into the eCRF. A copy of the original source documents will be stored within a locked cabinet/office accessible to authorized personnel only. An identifiable patient data page reporting the assigned patient identification code will be stored separately also in a locked cabinet/office (accessible to authorized personnel only) in order to record in-hospital outcomes, conduct follow-up, supply missing data points, and to allow potential monitoring visits by regulatory authorities. All collected data will be archived for a period of 15 years.

The secure database run by the clinical trials unit of the University Hospital Duesseldorf allows for data entry accountability and high security standards.

Drug and device information, study documents

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