Myocardial Infarction Clinical Trial
Official title:
High-sensitivity Troponin T in Acute Myocardial Infarction in Patients Undergoing Cardiac Valvular Surgery
A measurable degree of heart muscle tissue injury is expected in patients undergoing heart
valvular surgery. The level of this injury can be measured by cardiac biomarkers in blood
samples. Those biomarkers are used to diagnose an acute myocardial infarction.
Postoperative myocardial infarction (MI) is a frequent and important complication after
cardiac surgery with high morbidity and mortality. Therefore it is very important to
recognize any cardiac event in patients who undergo cardiac surgery. Different diagnostic
tools can be used to the diagnosis of acute myocardial infarction; however few is known
about the value of high-sensitivity cardiac troponin T (hs-cTn) to diagnose a MI after heart
valvular surgery.
The aim of this study is to determine the upper reference limit of high-sensitivity troponin
T concentration to consider the diagnosis of acute myocardial infarction in patients
undergoing heart valvular surgery.
This is a longitudinal prospective observational cohort mono centre study. Hs-cTn will be
measured at different point of times in adult patients undergoing heart valvular surgery
with cardiopulmonary bypass (CPB) and without recent medical history of ischemic heart
disease.
The study is conducted at the University Clinical Hospital of Valladolid, Spain. The Cardiac
Surgery department annually performs approximately 550 cardiac surgeries with CPB in adult
patients (approximately 300 heart valvular surgeries). Two operating rooms are routinely
used. There is an intensive care unit (ICU) with 10 beds dedicated exclusively to the
postoperative care of patients who undergo cardiac surgery.The hospital's research
commission approved the study. All patients, preoperatively, provided informed written
consent both for their heart surgery and for their participation in the study.
Serum levels of hs-cTn will be measured before cardiac surgery, upon arrival at the ICU, as
well as every 6 hours for 24 hours, then every 8 hours the following 24 hours and a last
blood sample will be taken 72 hours after cardiac surgery. Samples are analysed at the
department of Clinical Biochemistry of our hospital.
Twelve-lead electrocardiograms (ECGs) obtained the day prior to heart valvular surgery,
immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery will be
reviewed by a cardiologist to evidence signs of myocardial infarction (MI). All cardiac
events will be noted as The Third Global MI Task Force definition of MI describes.
A transthoracic echocardiography (TTE) will be also performed by a cardiologist after
cardiac valvular surgery to determine the ejection fraction of left ventricle and the
occurrence of a new regional wall motion abnormality. This TTE will be compared, by the same
cardiologist, with a TTE performed before cardiac valvular surgery.
The principal investigator will supervise data handling.
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Observational Model: Cohort, Time Perspective: Prospective
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