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

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 Overview

• Status: Recruiting
• Conditions: Coronary Bypass Graft Occlusion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: Denis Berdajs, Prof. Dr. med.; Phone Number: +41 61 328 71 80; Email: denis.berdajs@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Department for Cardiac Surgery, University Hospital Basel
    • Contact: Denis Berdajs, Prof. Dr. med.; Phone Number: +41 61 328 71 80; Email: denis.berdajs@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Cardiac-related mortality during hospital stay	Cardiac-related mortality during hospital stay	Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay	Myocardial infarction during hospital stay	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	Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay	Stroke rate during hospital stay	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.	Day 0 to discharge date (max 10 days)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Denis Berdajs, Prof. Dr. med., Department of Cardiac Surgery, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cardiac biomarkers; coronary artery bypass grafting (CABG); coronary revascularization; high-sensitivity cardiac troponin (hs-cTn); myocardial infarction (MI); Coronary Computed Tomography (CCT); early coronary bypass graft occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Graft Occlusion, Vascular
• Other Study ID Numbers: 2020-02257; ch20Berdajs

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No