NCT06066970 Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
| NCT ID | NCT06066970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jena University Hospital |
| Condition | Cardiac Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2025-09 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The aim of the study is to clarify whether the perioperative release of the cardiac biomarkers troponin I, troponin T and CK-MB consistently correlate with visualizable myocardial damage, and to what extent these biomarkers are comparable by means of their kinetics and dynamics. Due to the uncertainty regarding the validity of cardiac biomarkers in the diagnosis of myocardial infarction, the answer to these questions could have a considerable influence on internationally valid guidelines and definitions. International studies, especially in the field of coronary surgery and coronary artery disease treatment refer to these definitions, in particular, the adequate treatment of affected patients is directly dependent on them.
Eligibility Criteria
Inclusion Criteria: * Indication for isolated aortic or mitral valve surgery * Written informed consent * Age ≥ 18 years Exclusion Criteria: * Presence of coronary artery disease (excluded within the last 6 months) * Allergy to gadolinium * Cochlear implant * Deep brain stimulation * Individual factors excluding the performance of an MRI (e.g. claustrophobia of the patient) * Significantly reduced renal function (GFR \< 30ml/min) * Perioperative complications that may lead to myocardial damage (discontinuation of the study for the patient and exclusion from the analysis after primary study inclusion) * Need for extension of surgery (additional procedures on other heart valves, aorta, myocardium, or similar; exclusion after primary study inclusion possible) * Pregnancy or lactation