Clinical trial NCT02518282: High-sensitivity Troponin T in Acute Myocardial Infarction After Cardiac Valvular Surgery
Official title: High-sensitivity Troponin T in Acute Myocardial Infarction in Patients Undergoing Cardiac Valvular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Myocardial Infarction
Heart Valve Diseases
Keywords: high-sensitivity troponin T
Acute myocardial infarction
Heart valvular surgery
Cardiac surgery
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Determination of upper reference limit (URL) of high-sensitivity troponin T that strongly suggests substantial myocardial damage and necrosis.
timeFrame: 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.
Secondary outcomes:
measure: High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery
timeFrame: From 8 hours preoperatively to 72 hours postoperatively
measure: Number of patients with complications after heart valvular surgery.
timeFrame: After cardiac valvular surgery to 72 hours post-surgery.
Other outcomes:
measure: Twelve-lead ECGs.
timeFrame: The day prior to cardiac surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery.
measure: Transthoracic Echocardiography (TTE).
timeFrame: Before heart valvular surgery and after heart valvular surgery.
Locations:
city: Valladolid
country: Spain
facility: University Clinical Hospital of Valladolid
Study officials:
affiliation: University Clinical Hospital of Valladolid
name: Héctor Cubero Gallego, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinical Hospital of Valladolid
name: Eduardo Tamayo Gómez, MD, PhD
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Valladolid
name: José Alberto San Román Calvar, MD, PhD
role: STUDY_CHAIR
affiliation: University Clinical Hospital of Valladolid
name: José Ignacio Gómez Herreras, MD, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.