Evaluating cardiac biomarkers after heart surgery
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jena University Hospital Academic / other |
| Locations | 5 sites (Freiburg im Breisgau, Baden-Wurttemberg and 4 other locations) |
| Trial ID | NCT06066970 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require isolated aortic or mitral valve surgery.
Not a fit: Patients with coronary artery disease, significant renal impairment, or those who cannot undergo MRI will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Freiburg im Breisgau, Baden-Wurttemberg and 4 other locations
- 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
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.