Biomarkers for Postoperative Myocardial Infarction in Cardiac Surgery.

November 24, 2015 updated by: Dr. B. van Zaane, UMC Utrecht

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

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).

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing cardiac surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative myocardial infarction
Time Frame: 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.
30 days after cardiac surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: Bas van Zaane, Md, PhD, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Estimate)

November 25, 2015

Last Update Submitted That Met QC Criteria

November 24, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL46363.041.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe