NCT02518282|UnknownDMC
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Sponsor study identifier
observational
800
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 4, 2015
Actual (reported)August 7, 2015
Actual (reported)April 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Determination of upper reference limit (URL) of high-sensitivity troponin T that strongly suggests substantial myocardial damage and necrosis.
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.
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.
High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery
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.
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.
Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.
University Clinical Hospital of Valladolid
Valladolid, Spain, 47005, Spain
Thygesen K, Mair J, Katus H, Plebani M, Venge P, Collinson P, Lindahl B, Giannitsis E, Hasin Y, Galvani M, Tubaro M, Alpert JS, Biasucci LM, Koenig W, Mueller C, Huber K, Hamm C, Jaffe AS; Study Group on Biomarkers in Cardiology of the ESC Working Group on Acute Cardiac Care. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J. 2010 Sep;31(18):2197-204. doi: 10.1093/eurheartj/ehq251. Epub 2010 Aug 3.
Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AH, Christenson RH, Apple FS, Francis G, Tang W; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Clin Chem. 2007 Apr;53(4):552-74. doi: 10.1373/clinchem.2006.084194. Epub 2007 Mar 23. No abstract available.
Héctor Cubero Gallego, MD
University Clinical Hospital of Valladolid
Eduardo Tamayo Gómez, MD, PhD
University Clinical Hospital of Valladolid
José Alberto San Román Calvar, MD, PhD
University Clinical Hospital of Valladolid
José Ignacio Gómez Herreras, MD, PhD
University Clinical Hospital of Valladolid
First Submitted
August 4, 2015
First Posted
August 7, 2015
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Estimated (date passed)The Melatonin Adjunct in the Acute myocaRdial Infarction Treated With Angioplasty
From 8 hours preoperatively to 72 hours postoperatively
Number of patients with complications after heart valvular surgery.
After cardiac valvular surgery to 72 hours post-surgery.
Twelve-lead ECGs.
The day prior to cardiac surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery.
Transthoracic Echocardiography (TTE).
Before heart valvular surgery and after heart valvular surgery.
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.
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Wang TK, Stewart RA, Ramanathan T, Kang N, Gamble G, White HD. Diagnosis of MI after CABG with high-sensitivity troponin T and new ECG or echocardiogram changes: relationship with mortality and validation of the universal definition of MI. Eur Heart J Acute Cardiovasc Care. 2013 Dec;2(4):323-33. doi: 10.1177/2048872613496941. Epub 2013 Aug 5.
Lurati Buse GA, Koller MT, Grapow M, Bolliger D, Seeberger M, Filipovic M. The prognostic value of troponin release after adult cardiac surgery - a meta-analysis. Eur J Cardiothorac Surg. 2010 Feb;37(2):399-406. doi: 10.1016/j.ejcts.2009.05.054. Epub 2009 Aug 20.
Apple FS, Jesse RL, Newby LK, Wu AH, Christenson RH; National Academy of Clinical Biochemistry; IFCC Committee for Standardization of Markers of Cardiac Damage. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines: Analytical issues for biochemical markers of acute coronary syndromes. Circulation. 2007 Apr 3;115(13):e352-5. doi: 10.1161/CIRCULATIONAHA.107.182881. Epub 2007 Mar 23. No abstract available.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on behalf of the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. Glob Heart. 2012 Dec;7(4):275-95. doi: 10.1016/j.gheart.2012.08.001. Epub 2012 Sep 26. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 17, 2015
Record last verified: 2015-08
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