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Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06066970
Acronym
RORSCHACH
Enrollment
100
Registered
2023-10-04
Start date
2023-09-05
Completion date
2025-12-31
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Valve Disease

Keywords

Biomarker, Troponin, CK-MB, Perioperative Myocardial Infarction, LGE-cMRI

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).

Interventions

None listed

Sponsors

Jena University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Germany

Contacts

Primary ContactTulio Caldonazo, Dr.
tulio.caldonazo@med.uni-jena.de+49 36419322953
Backup ContactMarcus Winter
marcus.winter@med.uni-jena.de+49 36419396648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026