Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-01 @ 2:12 PM
Study NCT ID:
NCT04877795
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Copeptin and HFABP in Cardiac Surgery
Sponsor:
Heinrich-Heine University, Duesseldorf
Organization:
Study Overview
Official Title:
Predictive Value of Copeptin and Heart-Type Fatty Acid Binding Protein in Cardiac Surgery - A Multicenter Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRACTICE
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: