High-sensitivity Troponin in Cardiac Surgery

NCT01913873 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-03-18

No results posted yet for this study

Summary

Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction.

Postoperative heart infarction remains a frequent and important complication after heart surgery.Therefore it is important to recognize any cardiac event in patients who underwent heart surgery. Although different diagnostic tools can be used to recognize these events, few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction after heart surgery.

In this study the investigators will describe the concentration changes of those cardiac biomarkers over time in patients undergoing heart surgery, and the investigators will try to establish a upper level value who could indicate heart infarction.

Conditions

Interventions

OTHER

serum concentration changes cardiac biomarkers

Serum concentration determination for cardiac biomarkers (CK-MB and Hs-cTn) preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.

Sponsors & Collaborators

  • Roche Farma, S.A

    collaborator INDUSTRY
  • Onze Lieve Vrouw Hospital

    lead OTHER

Principal Investigators

  • Nathalie De Mey, MD · OLV Hospital Aalst, Belgium

  • Koen De Decker, MD · OLV Hospital Aalst, Belgium

  • Guy Cammu, MD,PhD · OLV Hospital Aalst, Belgium

  • Inger Brandt, MD · OLV Hospital Aalst, Belgium

  • Pierre Couture, MD · Montreal Heart Institute, Quebec, Canada

  • William Wijns, MD · OLV Hospital Aalst, Belgium

  • Jan Verbeke, MD · OLV Hospital Aalst, Belgium

  • Ivan Degrieck, MD · OLV Hospital Aalst, Belgium

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913873 on ClinicalTrials.gov