Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

Study Overview
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Brief Summary
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This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

Detailed Description
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The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

Official Title
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Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

Conditions
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Coronary Bypass Graft Occlusion

Intervention / Treatment
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* Other: data collection from the hospital records


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with isolated coronary bypass surgery Exclusion Criteria: Patients withholding or lacking informed consent Patients requiring a concomitant procedure Exclusion criteria concerning the CCT scan Patients with known allergy to iodine-containing contrast agents Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2). Pregnancy Unstable clinical state or severe heart failure Patients with registered MI and registered bypass occlusion in coronary angiogram Patients that didn't undergo a CCT prior to discharge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: data collection from the hospital records|The clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist device) and CCT scan data (at discharge from hospital facility) will be obtained from the hospital records. The data will be entered into a database.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hs-cTn level (ng/L) | hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT | Day 0 to discharge date (max 10 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality during hospital stay (death before discharge) | All-cause mortality during hospital stay (death before discharge) | Day 0 to discharge date (max 10 days) | 
| Cardiac-related mortality during hospital stay | Cardiac-related mortality during hospital stay | Day 0 to discharge date (max 10 days) | 
| Myocardial infarction during hospital stay | Myocardial infarction during hospital stay | Day 0 to discharge date (max 10 days) | 
| Surgical or percutaneous coronary re-intervention during hospital stay | Surgical or percutaneous coronary re-intervention during hospital stay | Day 0 to discharge date (max 10 days) | 
| Stroke rate during hospital stay | Stroke rate during hospital stay | Day 0 to discharge date (max 10 days) | 
| Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay | Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay. MACCE is defined as a combined event of in-hospital mortality, stroke and myocardial infarction. | Day 0 to discharge date (max 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass grafting (CABG), cardiac biomarkers, coronary revascularization, high-sensitivity cardiac troponin (hs-cTn), myocardial infarction (MI), Coronary Computed Tomography (CCT), early coronary bypass graft occlusion