Acute Myocardial InfarctionNCT02518282
High-sensitivity Troponin T in Acute Myocardial Infarction After Cardiac Valvular Surgery
An observational study of Acute Myocardial Infarction and Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by University of Valladolid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Disorder; Heart, Functional, Postoperative, Cardiac Surgery, Myocardial Infarction
- What is being tested?
- Serum levels of high-sensitivity troponin T, Twelve-lead ECGs and Transthoracic echocardiography (TTE)
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.
Who may be able to join
- 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.
Who cannot join
- Patients undergoing coronary bypass artery grafting (CABG).
- Patients with severe or end-stage renal insufficiency.
- Insertion of assist devices.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Clinical Hospital of Valladolid
Valladolid, Spain, 47005
Héctor Cubero, MD, +34649381490, hektorkubero@hotmail.com
About this study
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Disorder; Heart, Functional, Postoperative, Cardiac Surgery, Myocardial Infarction, Heart Valve Diseases
- Being tested
- Serum levels of high-sensitivity troponin T, Twelve-lead ECGs, Transthoracic echocardiography (TTE)
- Keywords
- high-sensitivity troponin T, Acute myocardial infarction, Heart valvular surgery, Cardiac surgery
- Medical subject headings
- Myocardial Infarction, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum levels of high-sensitivity troponin TOther
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 ECGsOther
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.
Transthoracic echocardiography (TTE)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery
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.
Measured: From 8 hours preoperatively to 72 hours postoperatively
Number of patients with complications after heart valvular 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.
Measured: After cardiac valvular surgery to 72 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Héctor Cubero Gallego, University of Valladolid
- Investigators
- Héctor Cubero Gallego, MD, Principal investigator, University Clinical Hospital of ValladolidEduardo Tamayo Gómez, MD, PhD, Study chair, University Clinical Hospital of ValladolidJosé Alberto San Román Calvar, MD, PhD, Study chair, University Clinical Hospital of ValladolidJosé Ignacio Gómez Herreras, MD, PhD, Study chair, University Clinical Hospital of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518282
- Sponsor's protocol ID
- PI 15-223 CINV 15-01
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2015
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20685679Morrow 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.
PubMed 17384001Wang 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.
PubMed 24338291Lurati 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.
PubMed 19699102Apple 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.
PubMed 17384332Thygesen 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.
PubMed 25689940
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-sensitivity Troponin T in Acute Myocardial Infarction in Patients Undergoing Cardiac Valvular Surgery
- ClinicalTrials.gov ID
- NCT02518282
- Acronym / sponsor ID
- PI 15-223 CINV 15-01
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (over 18 years old) undergoing heart valvular surgery with CPB.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients undergoing coronary bypass artery grafting (CABG).
- Patients with severe or end-stage renal insufficiency.
- Insertion of assist devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum levels of high-sensitivity troponin TSerum 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 ECGsTwelve-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. | Other | – |
Primary outcome
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.
2 secondary outcomes
High-sensitivity troponin T concentration changes over time in patients undergoing heart valvular surgery
Time frame: From 8 hours preoperatively to 72 hours postoperatively
Number of patients with complications after heart valvular surgery.
Time frame: After cardiac valvular surgery to 72 hours post-surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Results publication: PubMed 20685679Thygesen 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.
- Results publication: PubMed 17384001Morrow 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.
- Results publication: PubMed 24338291Wang 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.
- Results publication: PubMed 19699102Lurati 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.
- Results publication: PubMed 17384332Apple 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.
- Results publication: PubMed 25689940Thygesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Héctor Cubero Gallego, MD principal investigator
University Clinical Hospital of Valladolid
Eduardo Tamayo Gómez, MD, PhD study chair
University Clinical Hospital of Valladolid
José Alberto San Román Calvar, MD, PhD study chair
University Clinical Hospital of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Disorder; Heart, Functional, Postoperative, Cardiac Surgery, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Héctor Cubero, MD (+34649381490, hektorkubero@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02518282, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.