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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-09-05 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Tulio Caldonazo, Dr.
PRINCIPAL INVESTIGATOR
Jena University Hospital
Frequently Asked Questions
Who can join the NCT06066970 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06066970 currently recruiting?
Yes, NCT06066970 is actively recruiting participants. Contact the research team at tulio.caldonazo@med.uni-jena.de for enrollment information.
Where is the NCT06066970 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany, Ulm, Germany, Münster, Germany, Halle, Germany and 1 additional location.
Who is sponsoring the NCT06066970 clinical trial?
NCT06066970 is sponsored by Jena University Hospital. The principal investigator is Tulio Caldonazo, Dr. at Jena University Hospital. The trial plans to enroll 100 participants.