Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

NCT06066970 | Recruiting

• 1 other identifier: ZKSJ0156
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiac Valve Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Indication for isolated aortic or mitral valve surgery
• Written informed consent
• Age ≥ 18 years

You may not qualify if:

• 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)
• Pregnancy or lactation

Sponsors & Collaborators

• Jena University Hospital: lead

Study Sites (5)

Universitäts-Herzzentrum Freiburg • Bad Krozingen

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Universitätsklinikum Halle

Halle, Saxony-Anhalt, 06120, Germany

RECRUITING

Universitätsklinikum Jena

Jena, Thuringia, 07747, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 40918750 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling - analysis of cardiac biomarker release (Troponin I, Troponin T, CK-MB, CK).

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tulio Caldonazo, Dr.

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tulio Caldonazo, Dr.

CONTACT

+49 36419322953; tulio.caldonazo@med.uni-jena.de

Marcus Winter

CONTACT

+49 36419396648; marcus.winter@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 4, 2023
• Study Start: September 5, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

DE (5)