Evaluating cardiac biomarkers for early detection of bypass graft occlusion
Official title: Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
Run by University Hospital, Basel, Switzerland · NCT04595630 · Data updated 2026-11-12
This study is testing if measuring a specific heart protein can help doctors spot early signs of problems with bypass grafts in patients who have heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Zagreb and 2 other locations) |
| Status | Recruiting |
| Started | July 1, 2021 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT04595630 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients undergoing isolated coronary bypass surgery.
✕Probably not a fit
Patients with unstable clinical states, severe heart failure, or those requiring concomitant procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the relationship between high-sensitivity cardiac troponin (hs-cTn) levels and early coronary bypass graft occlusion in patients undergoing coronary artery bypass grafting (CABG). By utilizing non-invasive coronary computed tomography (CCT) scans, the study seeks to identify early signs of myocardial infarction (MI) related to graft occlusion, which is crucial for timely therapeutic interventions. The study will collect data from hospital records to establish the correlation between hs-cTn levels and graft occlusion outcomes. This approach addresses the need for safer diagnostic methods compared to invasive coronary angiography.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of bypass graft occlusion, potentially reducing the risk of myocardial infarction in patients post-surgery.
How similar studies have gone: Other studies have explored the use of cardiac biomarkers for similar purposes, indicating potential success in this area, though this specific approach may be novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Department for Cardiac Surgery, University Hospital Basel
Basel, Switzerland Recruiting -
University Hospital Centre Zagreb
Zagreb, Croatia Not yet recruiting -
Wroclaw Medical University
Wroclaw, Borowska, Poland Not yet recruiting
Study contacts
- Principal investigator: Denis Berdajs, Prof. Dr. med. — Department of Cardiac Surgery, University Hospital Basel
- Study coordinator: Denis Berdajs, Prof. Dr. med.
- Email: denis.berdajs@usb.ch
- Phone: +41 61 328 71 80
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.