Evaluating cardiac biomarkers after heart surgery
Official title: Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Run by Jena University Hospital · NCT06066970 · Data updated 2026-11-12
This study is trying to see if certain heart proteins released during heart surgery can help doctors understand how much heart damage patients have after they undergo aortic or mitral valve surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 5 sites (Freiburg im Breisgau, Baden-Wurttemberg and 4 other locations) |
| Status | Recruiting |
| Started | September 5, 2023 |
| Main results expected | September 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT06066970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who require isolated aortic or mitral valve surgery.
✕Probably not a fit
Patients with coronary artery disease, significant renal impairment, or those who cannot undergo MRI will 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 investigate the relationship between the perioperative release of cardiac biomarkers, specifically troponin I, troponin T, and CK-MB, and the actual myocardial damage observed in patients undergoing isolated aortic or mitral valve surgery. The study will assess whether elevations in these biomarkers correlate with visualizable myocardial damage and will analyze their kinetics and dynamics. By clarifying the validity of these biomarkers in diagnosing myocardial infarction, the findings could significantly influence international guidelines and treatment protocols for cardiac surgery patients.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and treatment strategies for patients undergoing cardiac surgery.
How similar studies have gone: While there have been studies on cardiac biomarkers, this specific correlation between perioperative ischemic damage and biomarker release has not been previously investigated, making this approach novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Universitäts-Herzzentrum Freiburg • Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting -
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany Recruiting -
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany Recruiting -
Universitätsklinikum Halle
Halle, Saxony-Anhalt, Germany Recruiting -
Universitätsklinikum Jena
Jena, Thuringia, Germany Recruiting
Study contacts
- Principal investigator: Tulio Caldonazo, Dr. — Jena University Hospital
- Study coordinator: Tulio Caldonazo, Dr.
- Email: tulio.caldonazo@med.uni-jena.de
- Phone: +49 36419322953
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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.