Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02569177
• Other study ID #: NL46363.041.14
• Status: Withdrawn
• Phase: N/A
• First received: September 28, 2015
• Last updated: November 24, 2015
• Start date: November 2015

Study information

• Verified date: November 2015
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

References & Publications (3)

Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99. — View Citation

Muehlschlegel JD, Perry TE, Liu KY, Fox AA, Collard CD, Shernan SK, Body SC. Heart-type fatty acid binding protein is an independent predictor of death and ventricular dysfunction after coronary artery bypass graft surgery. Anesth Analg. 2010 Nov;111(5):1101-9. doi: 10.1213/ANE.0b013e3181dd9516. Epub 2010 May 10. — View Citation

Yau JM, Alexander JH, Hafley G, Mahaffey KW, Mack MJ, Kouchoukos N, Goyal A, Peterson ED, Gibson CM, Califf RM, Harrington RA, Ferguson TB; PREVENT IV Investigators. Impact of perioperative myocardial infarction on angiographic and clinical outcomes following coronary artery bypass grafting (from PRoject of Ex-vivo Vein graft ENgineering via Transfection [PREVENT] IV). Am J Cardiol. 2008 Sep 1;102(5):546-51. doi: 10.1016/j.amjcard.2008.04.069. Epub 2008 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative myocardial infarction	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.	30 days after cardiac surgery	No
Secondary	Mortality		30-days and 1-year after cardiac surgery	No
Secondary	Hospital length of stay		1 year after cardiac surgery	No