An observational study in Coronary Bypass Graft Occlusion, sponsored by University Hospital, Basel, Switzerland. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by University Hospital, Basel, Switzerland · Observational
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.
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.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.
Inclusion Criteria:
Exclusion Criteria:
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.
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
Time frame: Day 0 to discharge date (max 10 days)
All-cause mortality during hospital stay (death before discharge)
All-cause mortality during hospital stay (death before discharge)
Time frame: Day 0 to discharge date (max 10 days)
Cardiac-related mortality during hospital stay
Cardiac-related mortality during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay
Myocardial infarction during hospital stay
Time frame: 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
Time frame: Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay
Stroke rate during hospital stay
Time frame: 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.
Time frame: Day 0 to discharge date (max 10 days)
All-cause mortality
All-cause mortality
Time frame: During one-year and 36 months follow up
Cardiac-related mortality
Cardiac-related mortality
Time frame: During one-year and 36 months follow up
Myocardial infarction
Myocardial infarction
Time frame: During one-year and 36 months follow up
Stroke
Stroke
Time frame: During one-year and 36 months follow up
Congestive heart failure requiring hospitalization
Congestive heart failure requiring hospitalization
Time frame: During one-year and 36 months follow up
Surgical or percutaneous coronary intervention
Surgical or percutaneous coronary intervention
Time frame: During one-year and 36 months follow up
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: During one-year and 36 months follow up
Correlation between intraoperative flow measurements and incidence of early bypass occlusion
Correlation between intraoperative flow measurements and incidence of early bypass occlusion
Time frame: Day 0 to discharge date (max 10 days)
Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period
Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period
Time frame: Day 0 to discharge date (max 10 days)
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Graft Occlusion, Vascular
University Hospital, Basel, Switzerland