Coronary Bypass Graft Occlusion
Conditions
Keywords
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
Brief summary
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
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.
Interventions
OTHERdata 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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with isolated coronary bypass surgery
Exclusion criteria
* Patients withholding or lacking informed consent * Patients requiring a concomitant procedure *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hs-cTn level (ng/L) | Day 0 to discharge date (max 10 days) | hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality during hospital stay (death before discharge) | Day 0 to discharge date (max 10 days) | All-cause mortality during hospital stay (death before discharge) |
| Cardiac-related mortality during hospital stay | Day 0 to discharge date (max 10 days) | Cardiac-related mortality during hospital stay |
| Myocardial infarction during hospital stay | Day 0 to discharge date (max 10 days) | Myocardial infarction during hospital stay |
| Stroke rate during hospital stay | Day 0 to discharge date (max 10 days) | Stroke rate during hospital stay |
| Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay | Day 0 to discharge date (max 10 days) | 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. |
| Surgical or percutaneous coronary re-intervention during hospital stay | Day 0 to discharge date (max 10 days) | Surgical or percutaneous coronary re-intervention during hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between intraoperative flow measurements and incidence of early bypass occlusion | Day 0 to discharge date (max 10 days) | Correlation between intraoperative flow measurements and incidence of early bypass occlusion |
| All-cause mortality | During one-year and 36 months follow up | All-cause mortality |
| Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period | Day 0 to discharge date (max 10 days) | Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period |
| Cardiac-related mortality | During one-year and 36 months follow up | Cardiac-related mortality |
| Myocardial infarction | During one-year and 36 months follow up | Myocardial infarction |
| Stroke | During one-year and 36 months follow up | Stroke |
| Congestive heart failure requiring hospitalization | During one-year and 36 months follow up | Congestive heart failure requiring hospitalization |
| Surgical or percutaneous coronary intervention | During one-year and 36 months follow up | Surgical or percutaneous coronary intervention |
| Incidence of major adverse cardiac and cerebrovascular events (MACCE) | During one-year and 36 months follow up | Incidence of major adverse cardiac and cerebrovascular events (MACCE) |
Countries
Croatia, Poland, Switzerland
Contacts
Primary ContactDenis Berdajs, Prof. Dr. med.
Outcome results
None listed