NCT02569177

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).

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

September 28, 2015

Last Update Submit

November 24, 2015

Conditions

Myocardial Infarction

Keywords

myocardial infarctioncardiac surgerytroponinheart-type fatty acid binding protein

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Mortality

    30-days and 1-year after cardiac surgery

  • Hospital length of stay

    1 year after cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing cardiac surgery.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 21304084BACKGROUND

  • 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.

    PMID: 18721510BACKGROUND

  • 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.

    PMID: 20457766BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be drawn before incision (baseline), during cardiopulmonary bypass and after release of the aortic cross clamp. Subsequently, blood samples will be drawn on arrival at the intensive care unit and three and six hours after arrival. On post-operative day 1 and 2 blood samples will be drawn on the ICU or the medium care. All samples will be stored according the hospital blood banking protocol and analyzed at once at the end of the study. Left over material will be discarded after all necessary analysis has been conducted.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Bas van Zaane, Md, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 28, 2015

First Posted

October 6, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Last Updated

November 25, 2015

Record last verified: 2015-11