Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

NCT ID: NCT06066970

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2025-12-31

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.

Detailed Description

In the course of a myocardial infarction, the death of cardiomyocytes leads to the release of specific cardiac biomarkers (CK-MB, troponin I and T). Since there is a general risk of perioperative infarction in cardiac surgery, the standard monitoring includes appropriate diagnostics. These are based on clinical symptoms, ECG, imaging (echocardiography or coronary angiography) and, in particular, the elevation of these cardiac biomarkers. Recently, the latter have been regularly moved into the foreground as the sole indicators of perioperative myocardial infarction, and first definitions allow the diagnosis solely based on troponin or CK-MB elevation.

However, biomarker elevations may not be accompanied by an image-morphologically detectable perfusion defect (myocardial infarction). Such phenomena have been described outside of cardiac surgery, for example, in marathon runners4, but also due to comorbidities such as renal insufficiency or neurological diseases. Even in patients undergoing cardiac surgery without coronary artery disease (e.g., isolated valve surgery), biomarker elevations up to the infarct-defining range are regularly observed. Whether in the latter case the perioperative routinely observed troponin or CK-MB elevation are indeed related to surgery-induced chronic perfusion disturbance has not yet been investigated.

To date, there is no study that quantitatively correlates purely perioperatively induced ischemic damage with the release of cardiac biomarkers. In addition, the three most commonly used biomarkers for perioperative infarct diagnosis differ considerably in their temporal release and release dynamics. Moreover, a direct comparison of all three parameters has never been performed so far.

Therefore, the aim of this study is to quantify and compare the release of troponin T, I and CK/CK-MB in the postoperative course in patients without relevant coronary artery disease undergoing elective isolated heart valve surgery. These findings will subsequently be correlated with classical diagnostics (clinic, ECG, echocardiography) and image morphological quantification of perioperatively induced myocardial damage by magnetic resonance imaging (LGE-cMRI).

Conditions

Cardiac Valve Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jena University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tulio Caldonazo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tulio Caldonazo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Locations

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Universitätsklinikum Halle

Halle, Saxony-Anhalt, Germany

Site Status: RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tulio Caldonazo, Dr.

Role: CONTACT

tulio.caldonazo@med.uni-jena.de

+49 36419322953

Marcus Winter

Role: CONTACT

marcus.winter@med.uni-jena.de

+49 36419396648

Facility Contacts

Tim Berger, Dr.

Role: primary

tim.berger@uniklinik-freiburg.de

+4976127028181

Andreas Liebold, Prof. Dr.

Role: primary

Andreas.Liebold@uniklinik-ulm.de

+4973150054303

André Peres

Role: backup

andre.peres@uniklinik-ulm.de

+4973150054406

Andreas Hoffmeier, Prof. Dr.

Role: primary

andreas.hoffmeier@ukmuenster.de

+492518344506

Vladyslava Stasii

Role: backup

Vladyslava.Stasii@ukmuenster.de

+492518344542

Gábor Szabó, Prof. Dr.

Role: primary

Gabor.Szabo@uk-halle.de

+349345557271

Tulio Caldonazo, Dr.

Role: primary

tulio.caldonazo@med.uni-jena.de

+49 36419322953

Marcus Winter

Role: backup

marcus.winter@med.uni-jena.de

+49 36419396648

References

Caldonazo T, Winter M, Kiehntopf M, Aschenbach R, Grager S, Reinartz S, Scherag A, Schumacher U, Kirov H, Teichgraber U, Doenst T; RORSCHACH Investigators and GermaN HeaRTS. Cardiac biomarkers for the quantification of myocardial damage after cardiac surgery - The RORSCHACH trial. Int J Cardiol Heart Vasc. 2025 Aug 28;60:101781. doi: 10.1016/j.ijcha.2025.101781. eCollection 2025 Oct.

Reference Type: DERIVED

PMID: 40918750 (View on PubMed)

Other Identifiers

ZKSJ0156

Identifier Type: -

Identifier Source: org_study_id