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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04595630

Collaborator

(none)

480

Enrollment

Location

Anticipated Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Bypass Graft Occlusion	Other: data collection from the hospital records

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

480 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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.

Other Outcome Measures

All-cause mortality [During one-year follow up]
All-cause mortality
Cardiac-related mortality [During one-year follow up]
Cardiac-related mortality
Myocardial infarction [During one-year follow up]
Myocardial infarction
Stroke [During one-year follow up]
Stroke
Congestive heart failure requiring hospitalization [During one-year follow up]
Congestive heart failure requiring hospitalization
Surgical or percutaneous coronary intervention [During one-year follow up]
Surgical or percutaneous coronary intervention
Incidence of major adverse cardiac and cerebrovascular events (MACCE) [During one-year follow up]
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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