Evaluating cardiac biomarkers for early detection of bypass graft occlusion
Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
University Hospital, Basel, Switzerland · NCT04595630
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 |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 3 sites (Zagreb and 2 other locations) |
| Trial ID | NCT04595630 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing isolated coronary bypass surgery.
Not a fit: Patients with unstable clinical states, severe heart failure, or those requiring concomitant procedures may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zagreb and 2 other locations
- University Hospital Centre Zagreb — Zagreb, Croatia (NOT_YET_RECRUITING)
- Wroclaw Medical University — Wroclaw, Borowska, Poland (NOT_YET_RECRUITING)
- Department for Cardiac Surgery, University Hospital Basel — Basel, Switzerland (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Bypass Graft Occlusion, coronary artery bypass grafting, cardiac biomarkers, coronary revascularization, high-sensitivity cardiac troponin, myocardial infarction, Coronary Computed Tomography, early coronary bypass graft occlusion