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

Coronary Bypass Graft Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595630
• Other study ID #: 2020-02257; ch20Berdajs
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 2029

Study information

• Verified date: September 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Denis Berdajs, Prof. Dr. med.
• Phone: +41 61 328 71 80
• Email: denis.berdajs[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Bypass Graft Occlusion
• Graft Occlusion, Vascular

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital Centre Zagreb	Zagreb
Poland	Wroclaw Medical University	Breslau	Borowska
Switzerland	Department for Cardiac Surgery, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Croatia,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality	All-cause mortality	During one-year and 36 months follow up
Other	Cardiac-related mortality	Cardiac-related mortality	During one-year and 36 months follow up
Other	Myocardial infarction	Myocardial infarction	During one-year and 36 months follow up
Other	Stroke	Stroke	During one-year and 36 months follow up
Other	Congestive heart failure requiring hospitalization	Congestive heart failure requiring hospitalization	During one-year and 36 months follow up
Other	Surgical or percutaneous coronary intervention	Surgical or percutaneous coronary intervention	During one-year and 36 months follow up
Other	Incidence of major adverse cardiac and cerebrovascular events (MACCE)	Incidence of major adverse cardiac and cerebrovascular events (MACCE)	During one-year and 36 months follow up
Other	Correlation between intraoperative flow measurements and incidence of early bypass occlusion	Correlation between intraoperative flow measurements and incidence of early bypass occlusion	Day 0 to discharge date (max 10 days)
Other	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	Day 0 to discharge date (max 10 days)
Primary	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	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)
Secondary	Cardiac-related mortality during hospital stay	Cardiac-related mortality during hospital stay	Day 0 to discharge date (max 10 days)
Secondary	Myocardial infarction during hospital stay	Myocardial infarction during hospital stay	Day 0 to discharge date (max 10 days)
Secondary	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)
Secondary	Stroke rate during hospital stay	Stroke rate during hospital stay	Day 0 to discharge date (max 10 days)
Secondary	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)