Copeptin and HFABP in Cardiac Surgery

Coronary Artery Disease Clinical Trial

— PRACTICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877795
• Other study ID #: V1.0
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Sebastian Roth, MD
• Phone: +492118118451
• Email: Sebastian.Roth[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

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).

Locations

Country	Name	City	State
Germany	Heinrich-Heine-Universität	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days alive and out of hospital	Patient-centered outcome to measure morbidity and mortality after surgery	At 30 days and 12 months after surgery
Secondary	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
Secondary	All cause mortality	Evaluate mortality after cardiac surgery	At 30 days and 12 months after surgery
Secondary	Length of ICU-stay	To observe the length and/or readmission rate of intensive care unit stay	At 30 days
Secondary	Acute kidney injury (AKI)	As defined by the three-stage KDIGO (Kidney Disease: Improving Global Outcome) classification of severity	At 30 days