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High-sensitivity Troponin T in Acute Myocardial Infarction After Cardiac Valvular Surgery

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ClinicalTrials.gov Identifier: NCT02518282
Recruitment Status : Unknown
Verified August 2015 by Héctor Cubero Gallego, University of Valladolid.
Recruitment status was:  Recruiting
First Posted : August 7, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Héctor Cubero Gallego, University of Valladolid

Brief Summary:

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.


Condition or disease Intervention/treatment
Acute Myocardial Infarction Disorder; Heart, Functional, Postoperative, Cardiac Surgery Myocardial Infarction Heart Valve Diseases Other: Serum levels of high-sensitivity troponin T Other: Twelve-lead ECGs Other: Transthoracic echocardiography (TTE)

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High-sensitivity Troponin T in Acute Myocardial Infarction in Patients Undergoing Cardiac Valvular Surgery
Study Start Date : January 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Serum levels of high-sensitivity troponin T
    Serum levels of hs-cTn will be measured before 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 surgery.
  • Other: Twelve-lead ECGs
    Twelve-lead 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 MI.
  • Other: Transthoracic echocardiography (TTE)
    A 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.


Primary Outcome Measures :
  1. Determination of upper reference limit (URL) of high-sensitivity troponin T that strongly suggests substantial myocardial damage and necrosis. [ Time Frame: Every 6 postoperative hours for the first 24 hours, then every 8 hours the following 24 hours and a last sample will be taken 72 hours after heart valvular surgery. ]
    Postoperative MI remains a frequent complication after cardiac surgery with high morbidity and mortality. In 2012 the Third Global MI Task Force presented the third universal definition of MI implying that MI associated with coronary artery bypass grafting (CABG) is arbitrarily defined by elevation of cardiac biomarkers values over 10 x 99th percentile URL in patients with normal baseline cTn values. In addition with either: a) new pathological Q waves or new left bundle branch block (LBBB), or b) angiographic documented new graft or new native coronary artery occlusion, or c) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Few is known about the established threshold values for hs-cTn after heart valvular surgery.


Secondary Outcome Measures :
  1. High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery [ Time Frame: From 8 hours preoperatively to 72 hours postoperatively ]
    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 heart valvular surgery.

  2. Number of patients with complications after heart valvular surgery. [ Time Frame: After cardiac valvular surgery to 72 hours post-surgery. ]
    To determine the number of patients with complications after heart valvular surgery and to determine which are the most frequent complications in patients undergoing cardiac valvular surgery.


Other Outcome Measures:
  1. Twelve-lead ECGs. [ Time Frame: The day prior to cardiac surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery. ]
    Twelve-lead ECGs will be reviewed by a cardiologist to evidence signs of postoperative MI.

  2. Transthoracic Echocardiography (TTE). [ Time Frame: Before heart valvular surgery and after heart valvular surgery. ]
    A TTE will be performed after heart valvular surgery to evidence a new regional wall motion abnormality. This TTE will be compared with a TTE performed before surgery.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.
Criteria

Inclusion Criteria:

  • Each participant must be older than 18 years.
  • Undergoing cardiac valvular surgery.
  • No recent clinical history of ischemic heart disease.
  • Each participant must voluntarily give his written informed consent.

Exclusion Criteria:

  • Patients undergoing coronary bypass artery grafting (CABG).
  • Patients with severe or end-stage renal insufficiency.
  • Insertion of assist devices.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518282


Contacts
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Contact: Héctor Cubero, MD +34649381490 hektorkubero@hotmail.com
Contact: Héctor Cubero, MD +34649381490 hektokubero@hotmail.com

Locations
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Spain
University Clinical Hospital of Valladolid Recruiting
Valladolid, Spain, 47005
Contact: Héctor Cubero, MD    +34649381490    hektorkubero@hotmail.com   
Sponsors and Collaborators
University of Valladolid
Investigators
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Principal Investigator: Héctor Cubero Gallego, MD University Clinical Hospital of Valladolid
Study Chair: Eduardo Tamayo Gómez, MD, PhD University Clinical Hospital of Valladolid
Study Chair: José Alberto San Román Calvar, MD, PhD University Clinical Hospital of Valladolid
Study Chair: José Ignacio Gómez Herreras, MD, PhD University Clinical Hospital of Valladolid
Publications of Results:

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Responsible Party: Héctor Cubero Gallego, MD, University of Valladolid
ClinicalTrials.gov Identifier: NCT02518282    
Other Study ID Numbers: PI 15-223 CINV 15-01
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Keywords provided by Héctor Cubero Gallego, University of Valladolid:
high-sensitivity troponin T
Acute myocardial infarction
Heart valvular surgery
Cardiac surgery
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Valve Diseases
Hypersensitivity
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Immune System Diseases