Clinical trial NCT04595630: Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
Official title: Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Bypass Graft Occlusion
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hs-cTn level (ng/L)
timeFrame: Day 0 to discharge date (max 10 days)
Secondary outcomes:
measure: All-cause mortality during hospital stay (death before discharge)
timeFrame: Day 0 to discharge date (max 10 days)
measure: Cardiac-related mortality during hospital stay
timeFrame: Day 0 to discharge date (max 10 days)
measure: Myocardial infarction during hospital stay
timeFrame: Day 0 to discharge date (max 10 days)
measure: Surgical or percutaneous coronary re-intervention during hospital stay
timeFrame: Day 0 to discharge date (max 10 days)
measure: Stroke rate during hospital stay
timeFrame: Day 0 to discharge date (max 10 days)
measure: Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay
timeFrame: Day 0 to discharge date (max 10 days)
Other outcomes:
measure: All-cause mortality
timeFrame: During one-year and 36 months follow up
measure: Cardiac-related mortality
timeFrame: During one-year and 36 months follow up
measure: Myocardial infarction
timeFrame: During one-year and 36 months follow up
measure: Stroke
timeFrame: During one-year and 36 months follow up
measure: Congestive heart failure requiring hospitalization
timeFrame: During one-year and 36 months follow up
measure: Surgical or percutaneous coronary intervention
timeFrame: During one-year and 36 months follow up
measure: Incidence of major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: During one-year and 36 months follow up
measure: Correlation between intraoperative flow measurements and incidence of early bypass occlusion
timeFrame: Day 0 to discharge date (max 10 days)
measure: Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period
timeFrame: Day 0 to discharge date (max 10 days)
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Breslau
country: Poland
facility: Wroclaw Medical University
state: Borowska
city: Basel
country: Switzerland
facility: Department for Cardiac Surgery, University Hospital Basel
Study officials:
affiliation: Department of Cardiac Surgery, University Hospital Basel
name: Denis Berdajs, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: