Clinical trial NCT02569177: Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.
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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Infarction
Keywords: myocardial infarction
cardiac surgery
troponin
heart-type fatty acid binding protein
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative myocardial infarction
timeFrame: 30 days after cardiac surgery
Secondary outcomes:
measure: Mortality
timeFrame: 30-days and 1-year after cardiac surgery
measure: Hospital length of stay
timeFrame: 1 year after cardiac surgery
Other outcomes:
Locations:
Study officials:
affiliation: UMC Utrecht
name: Bas van Zaane, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.