Heart; Dysfunction Postoperative, Cardiac SurgeryPhase 4NCT01913873
High-sensitivity Troponin in Cardiac Surgery
A Phase 4 study testing serum concentration changes cardiac biomarkers in people with Heart; Dysfunction Postoperative, Cardiac Surgery and Myocardial Infarction, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery, Myocardial Infarction, Myocardial Injury
- What is being tested?
- serum concentration changes cardiac biomarkers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Mar 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Each participant must be older than 18 years
- Undergoing cardiac surgery
- Each participant must have the mental capacity to decide whether he takes part in the trial or not.
- Each participant must voluntarily give his written informed consent.
Who cannot join
- Patients with severe or end-stage renal insufficiency.
- Insertion of assist devices.
- Surgery on urgent basis, that is, the same day after their coronary angiogram.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Intensive Care Unit, OLV Hospital Aalst, Belgium
Aalst, East-Flanders, 9300
About this study
Official title: High-sensitivity Cardiac Troponin and CK-MB Concentrations in Patients Undergoing Cardiac Surgery
Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction.
Postoperative heart infarction remains a frequent and important complication after heart surgery.Therefore it is important to recognize any cardiac event in patients who underwent heart surgery. Although different diagnostic tools can be used to recognize these events, few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction after heart surgery.
In this study the investigators will describe the concentration changes of those cardiac biomarkers over time in patients undergoing heart surgery, and the investigators will try to establish a upper level value who could indicate heart infarction.
Read the detailed description
This is a prospective interventional mono centre study. High-sensitivity troponin and CK-MB will be measured at different point of times in all adult patients undergoing cardiac surgery.
Experiments are conducted at the O.L.V. Hospital, Aalst, Belgium, in a fully equipped operating room and intensive care facility and in the presence of board-certified anesthesiologists for safety reasons. After approval by the institutional ethics committee and written informed consent, all adult patients scheduled for different types of cardiac surgery between June 2013 and June 2014 will be enrolled. Collected data include demographic information, presence of co-morbid conditions and basic preoperative laboratory testing (including Hs-cTn and CK-MB) (Table 1) as well as per- and postoperative factors (Table 2).
Four different surgeons will perform the surgeries. The revascularization strategy and work method are chosen according to each surgeon's preference and good clinical practice. Standard monitoring is used in all patients. Anaesthesia management is at the discretion of the attending anaesthesiologist and according to good clinical practice.
Serum levels of CK-MB and Hs-cTn will be measured at induction of anaesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery. Samples are analysed at the department of Clinical Biochemistry of our institution with the Elecsys Troponin T hs immuno-assay. Lower limit of quantification being 0,14 Nano gram/L (company data).
Twelve-lead ECGs obtained routinely the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI.
All cardiac events, as described by the Third Global MI Task Force definition of MI, will be noted. Additional ECG or transesophageal echocardiography will be done at the discretion of the attending ICU physician, according to ICU protocols and good clinical practice.
Approved automated record keeping system (MetaVision Suite, iMDSoft, the Netherlands) will be used in the ICU. The principal investigator and/or co-investigators will supervise data handling.
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery, Myocardial Infarction, Myocardial Injury
- Being tested
- serum concentration changes cardiac biomarkers
- Keywords
- High-sensitivity Cardiac Troponin, Creatinin Kinase MB, Cardiac Surgery, Myocardial injury, Myocardial infarction, Concentration change
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum concentration changes cardiac biomarkersOther
Serum concentration determination for cardiac biomarkers (CK-MB and Hs-cTn) preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac biomarkers concentration changes | Experimental | In 2012 the Third Global MI Task Force has presented a third universal definition of MI implying that MI associated with CABG is arbitrarily defined by elevation of cardiac biomarkers values > 10x99th percentile URL in patients with normal baseline cTn values (≤ 99th percentile URL), in addition with either (i) new pathological Q waves or new LBBB (left bundle branch block), or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
In this study we will measure the concentration changes over time of cardiac biomarkers (hs-cTN and CK-MB) and establish a threshold value for myocardial injury, diagnosed by ECG and approved -if necessary- by echocardiography. Receives: Other: serum concentration changes cardiac biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery
Serum levels of Hs-cTn (high-sensitivity cardiac troponin assays) will be measured from 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
Measured: from 12 hours preoperatively to 48 hours postoperatively
CK-MB concentration changes over time in patients undergoing cardiac surgery
Serum levels of CK-MB will be measured 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
Measured: From 12 hours preoperatively to 48 hours postoperatively
Secondary outcomes (1)
Determination of threshold values for high-sensitivity troponin T and CK-MB cardiac biomarkers that strongly suggest substantial myocardial damage and necrosis.
Postoperative myocardial infarction remains a frequent and important complication after cardiac surgery. In 2012 the Third Global MI Task Force has presented a third universal definition of myocardial infarction (MI) implying that MI associated with coronary artery bypass grafting (CABG) is arbitrarily defined by elevation of cardiac biomarkers values > 10x99th percentile URL in patients with normal baseline cTn values (≤ 99th percentile URL), in addition with either (i) new pathological Q waves or new LBBB (left bundle branch block), or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Although some suggest that ECG, myocardial scan, and CK-MB criteria underestimate the prevalence of MI after CABG, few is known about the established threshold values for hs-cTn after valve surgery or combined surgery.
Measured: every 3 postoperative hours for the first 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMar 2015
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 Heart; Dysfunction Postoperative, Cardiac SurgeryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Farma, S.A
- Responsible party
- Principal investigator, Guy CAMMU, Onze Lieve Vrouw Hospital
- Investigators
- Nathalie De Mey, MD, Principal investigator, OLV Hospital Aalst, BelgiumKoen De Decker, MD, Principal investigator, OLV Hospital Aalst, BelgiumGuy Cammu, MD,PhD, Principal investigator, OLV Hospital Aalst, BelgiumInger Brandt, MD, Study chair, OLV Hospital Aalst, BelgiumPierre Couture, MD, Study chair, Montreal Heart Institute, Quebec, CanadaWilliam Wijns, MD, Study chair, OLV Hospital Aalst, BelgiumJan Verbeke, MD, Study chair, OLV Hospital Aalst, BelgiumIvan Degrieck, MD, Study chair, OLV Hospital Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913873
- Sponsor's protocol ID
- NATH201301
- Status last verified
- Mar 2015
- First submitted
- 29 Jul 2013
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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; 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. Circulation. 2007 Apr 3;115(13):e356-75. doi: 10.1161/CIRCULATIONAHA.107.182882. Epub 2007 Mar 23. No abstract available.
PubMed 17384331Apple 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 17384332Carrier M, Pellerin M, Perrault LP, Solymoss BC, Pelletier LC. Troponin levels in patients with myocardial infarction after coronary artery bypass grafting. Ann Thorac Surg. 2000 Feb;69(2):435-40. doi: 10.1016/s0003-4975(99)01294-1.
PubMed 10735677Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
PubMed 22922414Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP. Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers. Circulation. 2004 Jan 27;109(3):345-50. doi: 10.1161/01.CIR.0000109489.71945.BD. Epub 2004 Jan 19.
PubMed 14732755
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-sensitivity Cardiac Troponin and CK-MB Concentrations in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01913873
- Acronym / sponsor ID
- NATH201301
- Conditions
- Heart; Dysfunction Postoperative, Cardiac Surgery, Myocardial Infarction, Myocardial Injury
- Keywords
- High-sensitivity Cardiac Troponin, Creatinin Kinase MB, Cardiac Surgery, Myocardial injury, Myocardial infarction, Concentration change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Collaborators
- Roche Farma, S.A
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Aug 2013 (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.
Among patients undergoing heart surgery, a measurable degree of heart muscle tissue injury is expected. The level of injury can be shown by measuring the blood levels of specific molecules called cardiac biomarkers. Those cardiac biomarkers are often used in the acute cardiac care to diagnose a myocardial infarction.
Postoperative heart infarction remains a frequent and important complication after heart surgery.Therefore it is important to recognize any cardiac event in patients who underwent heart surgery. Although different diagnostic tools can be used to recognize these events, few is known about the value of those cardiac biomarkers to diagnose a myocardial infarction after heart surgery.
In this study the investigators will describe the concentration changes of those cardiac biomarkers over time in patients undergoing heart surgery, and the investigators will try to establish a upper level value who could indicate heart infarction.
Detailed description
This is a prospective interventional mono centre study. High-sensitivity troponin and CK-MB will be measured at different point of times in all adult patients undergoing cardiac surgery.
Experiments are conducted at the O.L.V. Hospital, Aalst, Belgium, in a fully equipped operating room and intensive care facility and in the presence of board-certified anesthesiologists for safety reasons. After approval by the institutional ethics committee and written informed consent, all adult patients scheduled for different types of cardiac surgery between June 2013 and June 2014 will be enrolled. Collected data include demographic information, presence of co-morbid conditions and basic preoperative laboratory testing (including Hs-cTn and CK-MB) (Table 1) as well as per- and postoperative factors (Table 2).
Four different surgeons will perform the surgeries. The revascularization strategy and work method are chosen according to each surgeon's preference and good clinical practice. Standard monitoring is used in all patients. Anaesthesia management is at the discretion of the attending anaesthesiologist and according to good clinical practice.
Serum levels of CK-MB and Hs-cTn will be measured at induction of anaesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery. Samples are analysed at the department of Clinical Biochemistry of our institution with the Elecsys Troponin T hs immuno-assay. Lower limit of quantification being 0,14 Nano gram/L (company data).
Twelve-lead ECGs obtained routinely the day prior to surgery, immediately upon arrival at the ICU, and then 24 and 48 hours post-surgery will be retrospectively reviewed by a cardiologist blinded to all other data for evidence of new postoperative MI.
All cardiac events, as described by the Third Global MI Task Force definition of MI, will be noted. Additional ECG or transesophageal echocardiography will be done at the discretion of the attending ICU physician, according to ICU protocols and good clinical practice.
Approved automated record keeping system (MetaVision Suite, iMDSoft, the Netherlands) will be used in the ICU. The principal investigator and/or co-investigators will supervise data handling.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac biomarkers concentration changes | Experimental | Other: serum concentration changes cardiac biomarkersIn 2012 the Third Global MI Task Force has presented a third universal definition of MI implying that MI associated with CABG is arbitrarily defined by elevation of cardiac biomarkers values > 10x99th percentile URL in patients with normal baseline cTn values (≤ 99th percentile URL), in addition with either (i) new pathological Q waves or new LBBB (left bundle branch block), or (ii) angiographic documented new graft or new native coronary artery occlusion, or (iii) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. In this study we will measure the concentration changes over time of cardiac biomarkers (hs-cTN and CK-MB) and establish a threshold value for myocardial injury, diagnosed by ECG and approved -if necessary- by echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Each participant must be older than 18 years
- Undergoing cardiac surgery
- Each participant must have the mental capacity to decide whether he takes part in the trial or not.
- Each participant must voluntarily give his written informed consent.
Key exclusion criteria (3 listed)
- Patients with severe or end-stage renal insufficiency.
- Insertion of assist devices.
- Surgery on urgent basis, that is, the same day after their coronary angiogram.
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 concentration changes cardiac biomarkersSerum concentration determination for cardiac biomarkers (CK-MB and Hs-cTn) preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery. | Other | Cardiac biomarkers concentration changes |
Primary outcome
high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery
Time frame: from 12 hours preoperatively to 48 hours postoperatively
Serum levels of Hs-cTn (high-sensitivity cardiac troponin assays) will be measured from 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
CK-MB concentration changes over time in patients undergoing cardiac surgery
Time frame: From 12 hours preoperatively to 48 hours postoperatively
Serum levels of CK-MB will be measured 12 hours preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
1 secondary outcome
Determination of threshold values for high-sensitivity troponin T and CK-MB cardiac biomarkers that strongly suggest substantial myocardial damage and necrosis.
Time frame: every 3 postoperative hours for the first 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
- Background: 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.
- Background: PubMed 17384331Morrow DA, Cannon CP, Jesse RL, Newby LK, Ravkilde J, Storrow AB, Wu AH, Christenson RH; 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. Circulation. 2007 Apr 3;115(13):e356-75. doi: 10.1161/CIRCULATIONAHA.107.182882. Epub 2007 Mar 23. No abstract available.
- Background: 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.
- Background: PubMed 10735677Carrier M, Pellerin M, Perrault LP, Solymoss BC, Pelletier LC. Troponin levels in patients with myocardial infarction after coronary artery bypass grafting. Ann Thorac Surg. 2000 Feb;69(2):435-40. doi: 10.1016/s0003-4975(99)01294-1.
- Background: PubMed 22922414Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 14732755Selvanayagam JB, Petersen SE, Francis JM, Robson MD, Kardos A, Neubauer S, Taggart DP. Effects of off-pump versus on-pump coronary surgery on reversible and irreversible myocardial injury: a randomized trial using cardiovascular magnetic resonance imaging and biochemical markers. Circulation. 2004 Jan 27;109(3):345-50. doi: 10.1161/01.CIR.0000109489.71945.BD. Epub 2004 Jan 19.
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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.
Nathalie De Mey, MD principal investigator
OLV Hospital Aalst, Belgium
Koen De Decker, MD principal investigator
OLV Hospital Aalst, Belgium
Guy Cammu, MD,PhD principal investigator
OLV Hospital Aalst, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing serum concentration changes cardiac biomarkers in people with Heart; Dysfunction Postoperative, Cardiac Surgery and Myocardial Infarction, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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: finished, as of the sponsor's last update on 18 Mar 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-sensitivity troponin T concentration changes over time in patients undergoing cardiac surgery (time frame: from 12 hours preoperatively to 48 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT01913873, 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 18 Mar 2015.