Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

Withdrawn

• Conditions: Myocardial Infarction

• Registration Number: NCT02569177
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Status Verified: 2015-11
• Study Start: 2015-11
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	30-days and 1-year after cardiac surgery
Hospital length of stay	1 year after cardiac surgery