Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

Evaluation of the Association Between Heart Type Fatty-acid Binding Proteins and High Sensitive Troponin and Postoperative Myocardial Infarction in Patients Undergoing Cardiac Surgery.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02569177

Enrollment

Registered

2015-10-06

Start date

2015-11-30

Completion date

Unknown

Last updated

2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, cardiac surgery, troponin, heart-type fatty acid binding protein

Brief 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. 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).

Detailed description

Specific aims: 1. To obtain an estimate of the association between a new very early marker of postoperative myocardial injury H-FABP and postoperative myocardial infarction. 2. To obtain an estimate of the association between cTn-I and postoperative myocardial infarction. 3. To obtain an estimate of the correlation between H-FABP elevation and cTn-I elevation in patients undergoing cardiac surgery.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years or older * isolated coronary artery bypass grafting * isolated valve surgery * combined coronary artery bypass grafting and valve surgery

Exclusion criteria

* emergency surgery patients * (suspected) sepsis * pulmonary embolism * renal failure (Glomerular filtration rate \< 40 ml/min) * off pump cardiac surgery

Design outcomes

Primary

Measure	Time frame	Description
Postoperative myocardial infarction	30 days after cardiac surgery	The occurence of postoperative myocardial infarction is imported from the Board Heart interventions Netherlands registry (BHN registry). For every patient undergoing cardiac surgery in the UMCU the cardiothoracic department determines whether the patient had a postoperative myocardial infarction or not and fills out the related information in the BHN registry.

Secondary

Measure	Time frame
Mortality	30-days and 1-year after cardiac surgery
Hospital length of stay	1 year after cardiac surgery

Outcome results