Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection from the hospital records.
- Who it may be relevant to
- Registry conditions: Coronary Bypass Graft Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia, Poland, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other data collection from the hospital records
The clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist devic
Primary outcome measures
- Change in hs-cTn level (ng/L) [Time frame: Day 0 to discharge date (max 10 days)]
Secondary outcome measures (6)
- All-cause mortality during hospital stay (death before discharge) [Time frame: Day 0 to discharge date (max 10 days)]
- Cardiac-related mortality during hospital stay [Time frame: Day 0 to discharge date (max 10 days)]
- Myocardial infarction during hospital stay [Time frame: Day 0 to discharge date (max 10 days)]
- Surgical or percutaneous coronary re-intervention during hospital stay [Time frame: Day 0 to discharge date (max 10 days)]
- Stroke rate during hospital stay [Time frame: Day 0 to discharge date (max 10 days)]
- Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay [Time frame: Day 0 to discharge date (max 10 days)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Croatia · 1 center
- University Hospital Centre Zagreb — Zagreb
Poland · 1 center
- Wroclaw Medical University — Wroclaw
Switzerland · 1 center
- Department for Cardiac Surgery, University Hospital Basel — Basel
Publications
- Salikhanov I, Koechlin L, Gahl B, Voehringer L, Reuthebuch O, Dimanski D, Mawad BM, Berdajs D. Survival, adverse events and management of silent in-hospital coronary bypass graft occlusion. Open Heart. 2025 Jul 7;12(2):e003368. doi: 10.1136/openhrt-2025-003368. PMID 40623893
Identifiers
NCT: NCT04595630 · 2020-02257; ch20Berdajs