Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913873
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2013-07-29
Brief Title:
High-sensitivity Troponin in Cardiac Surgery
Sponsor:
Onze Lieve Vrouw Hospital
Organization:
Onze Lieve Vrouw Hospital
Study Overview
Official Title:
High-sensitivity Cardiac Troponin and CK-MB Concentrations in Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 surgeryTherefore 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
Postoperative heart infarction remains a frequent and important complication after heart surgeryTherefore 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
Detailed Description:
This is a prospective interventional mono centre study High-sensitivity troponin and CK-MB will be measured at different point of times in all adult patients undergoing cardiac surgery
Experiments are conducted at the OLV Hospital Aalst Belgium in a fully equipped operating room and intensive care facility and in the presence of board-certified anesthesiologists for safety reasons After approval by the institutional ethics committee and written informed consent all adult patients scheduled for different types of cardiac surgery between June 2013 and June 2014 will be enrolled Collected data include demographic information presence of co-morbid conditions and basic preoperative laboratory testing including Hs-cTn and CK-MB Table 1 as well as per- and postoperative factors Table 2
Four different surgeons will perform the surgeries The revascularization strategy and work method are chosen according to each surgeons preference and good clinical practice Standard monitoring is used in all patients Anaesthesia management is at the discretion of the attending anaesthesiologist and according to good clinical practice
Serum levels of CK-MB and Hs-cTn will be measured at induction of anaesthesia 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 Samples are analysed at the department of Clinical Biochemistry of our institution with the Elecsys Troponin T hs immuno-assay Lower limit of quantification being 014 Nano gramL company data
Twelve-lead ECGs obtained routinely the day prior to surgery immediately upon arrival at the ICU and then 24 and 48 hours post-surgery will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI
All cardiac events as described by the Third Global MI Task Force definition of MI will be noted Additional ECG or transesophageal echocardiography will be done at the discretion of the attending ICU physician according to ICU protocols and good clinical practice
Approved automated record keeping system MetaVision Suite iMDSoft the Netherlands will be used in the ICU The principal investigator andor co-investigators will supervise data handling
Experiments are conducted at the OLV Hospital Aalst Belgium in a fully equipped operating room and intensive care facility and in the presence of board-certified anesthesiologists for safety reasons After approval by the institutional ethics committee and written informed consent all adult patients scheduled for different types of cardiac surgery between June 2013 and June 2014 will be enrolled Collected data include demographic information presence of co-morbid conditions and basic preoperative laboratory testing including Hs-cTn and CK-MB Table 1 as well as per- and postoperative factors Table 2
Four different surgeons will perform the surgeries The revascularization strategy and work method are chosen according to each surgeons preference and good clinical practice Standard monitoring is used in all patients Anaesthesia management is at the discretion of the attending anaesthesiologist and according to good clinical practice
Serum levels of CK-MB and Hs-cTn will be measured at induction of anaesthesia 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 Samples are analysed at the department of Clinical Biochemistry of our institution with the Elecsys Troponin T hs immuno-assay Lower limit of quantification being 014 Nano gramL company data
Twelve-lead ECGs obtained routinely the day prior to surgery immediately upon arrival at the ICU and then 24 and 48 hours post-surgery will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI
All cardiac events as described by the Third Global MI Task Force definition of MI will be noted Additional ECG or transesophageal echocardiography will be done at the discretion of the attending ICU physician according to ICU protocols and good clinical practice
Approved automated record keeping system MetaVision Suite iMDSoft the Netherlands will be used in the ICU The principal investigator andor co-investigators will supervise data handling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None