The objective is to estimate the association between biomarkers of myocardial injury and myocardial infarction in patients undergoing cardiac surgery. Myocardial infarction will be established with both a new and very early marker of myocardial…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements: From all patients* blood samples will be obtained before, during
and after surgery to measure H-FABP en troponin levels. Other relevant
information will be obtained from the Electronic Patient Record system and from
the Anesthesia Information and Management System (AIMS).
The primary end-point is myocardial infarction. The occurence of postoperative
myocardial infarction is imported from the Board Heart interventions
Netherlands registry (BHN registry). This particular item is standardly filled
out for all cardiac surgery patients in this hospital by the department of
cardiology independent of this research.
Secondary outcome
The secondary endpoint is mortality and hospital length of stay.
Background summary
Myocardial infarction and subsequent myocardial injury after cardiac surgery
occurs in 7-15% of patients undergoing cardiac surgery and is associated with
an increased length of stay, and reduced short- and long-term survival. Cardiac
troponin is considered to be a cornerstone in the diagnosis of a myocardial
infarction. Heart-type Fatty Acid-Binding Protein (H-FABP) is a new sensitive
biomarker for myocardial injury. The effectiveness of using the combination of
H-FABP with Troponin to diagnose myocardial injury within 6 hours after the
onset of ischemia is well reported. Previous studies in non-surgical patients
have associated increased H-FABP with an increased risk of subsequent death and
major cardiac events. The prognostic value in cardiac surgery patients has not
been studied extensively.
Study objective
The objective is to estimate the association between biomarkers of myocardial
injury and myocardial infarction in patients undergoing cardiac surgery.
Myocardial infarction will be established with both a new and very early marker
of myocardial injury (Heart-type Fatty Acid Binding Proteins) as well as to a
known early marker of such injury (Cardiac troponin).
Study design
This is a prospective observational cohort study.
Study burden and risks
For study purposes, nine blood samples will be drawn. The burden for the
participants will be minimal as five blood samples are combined with blood
sampling for medical care. Four of the blood samples are taken under general
anesthesia. The samples will be taken from either the arterial line or central
venous line. Risks are negligible as the above mentioned blood sampling methods
are all considered as safe.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients over 18 years, undergoing isolated coronary artery bypass grafting (CABG), isolated valve surgery (aortic valve replacement, mitral valve repair or replacement) or combined CABG and valve surgery in the University Medical Center Utrecht
Exclusion criteria
Emergency surgery, (suspected) sepsis or pulmonary embolism, renal failure (defined as Glomerular Filtration Rate < 40 ml/min).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46363.041.14 |