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

Recruiting

• Conditions: Coronary Bypass Graft Occlusion

• Registration Number: NCT04595630
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2021-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (3)

Wroclaw Medical University; 🇵🇱 Breslau, Borowska, Poland

Department for Cardiac Surgery, University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia