Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

NCT06066970 · tracked via the Priya Life Science Germany tracker

Sponsor

Jena University Hospital

Phase

Observational

Started

2023-09-05

Last updated

2025-09-26

Condition(s) studied

Cardiac Valve Disease

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Correlation biomarker release and LGE-cMRI — pre-surgery and 5 days post-surgery
Correlation of the peak value of the respective biomarker with the amount of perioperatively induced myocardial damage quantified by LGE-cMRI.

Trial sites (5)

Facility	City	Region	Status
Universitäts-Herzzentrum Freiburg • Bad Krozingen	Freiburg im Breisgau	Baden-Wurttemberg	Recruiting
Universitätsklinikum Ulm	Ulm	Baden-Wurttemberg	Recruiting
Universitätsklinikum Münster	Münster	North Rhine-Westphalia	Recruiting
Universitätsklinikum Halle	Halle	Saxony-Anhalt	Recruiting
Universitätsklinikum Jena	Jena	Thuringia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06066970 on ClinicalTrials.gov ↗ ← All trials in Germany