Copeptin and HFABP in Cardiac Surgery (PRACTICE)

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Coronary Artery Disease; Valvular Heart Disease

Treatments: Diagnostic Test: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT04877795

V1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 1 patient group

Cardiac Surgery

Description:

Adult Patients undergoing elective on-pump cardiac surgery (i.e. Coronary artery bypass graft surgery (CABG) and/or valvular surgery)

Treatment:

Diagnostic Test: Blood sampling