Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery (RORSCHACH)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Valve Disease

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).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tulio Caldonazo, Dr.; Phone Number: +49 36419322953; Email: tulio.caldonazo@med.uni-jena.de
• Study Contact Backup: Name: Marcus Winter; Phone Number: +49 36419396648; Email: marcus.winter@med.uni-jena.de

Study Locations

• Germany
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Recruiting
      • Universitäts-Herzzentrum Freiburg • Bad Krozingen
      • Contact: Tim Berger, Dr.; Phone Number: +4976127028181; Email: tim.berger@uniklinik-freiburg.de
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Recruiting
      • Universitätsklinikum Ulm
      • Contact: Andreas Liebold, Prof. Dr.; Phone Number: +4973150054303; Email: Andreas.Liebold@uniklinik-ulm.de
      • Contact: André Peres; Phone Number: +4973150054406; Email: andre.peres@uniklinik-ulm.de
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Recruiting
      • Universitatsklinikum Munster
      • Contact: Andreas Hoffmeier, Prof. Dr.; Phone Number: +492518344506; Email: andreas.hoffmeier@ukmuenster.de
      • Contact: Vladyslava Stasii; Phone Number: +492518344542; Email: Vladyslava.Stasii@ukmuenster.de
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • Recruiting
      • Universitätsklinikum Halle
      • Contact: Gábor Szabó, Prof. Dr.; Phone Number: +349345557271; Email: Gabor.Szabo@uk-halle.de
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • Recruiting
      • Universitätsklinikum Jena
      • Contact: Tulio Caldonazo, Dr.; Phone Number: +49 36419322953; Email: tulio.caldonazo@med.uni-jena.de
      • Contact: Marcus Winter; Phone Number: +49 36419396648; Email: marcus.winter@med.uni-jena.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with indication for isolated aortic or mitral valve surgery and exclusion of coronary artery disease.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Investigators: Principal Investigator: Tulio Caldonazo, Dr., Jena University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Biomarker; Troponin; CK-MB; Perioperative Myocardial Infarction; LGE-cMRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: ZKSJ0156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet decided in which way and which data exactly will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No