Cardiac Valve DiseaseRORSCHACHNCT06066970
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
An observational study of Cardiac Valve Disease, run by Jena University Hospital at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease
- How many people
- 100 participants
- Where
- 5 sitesGermany
- Study dates
- 5 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for isolated aortic or mitral valve surgery and exclusion of coronary artery disease.
Who may be able to join
- Indication for isolated aortic or mitral valve surgery
- Written informed consent
- Age ≥ 18 years
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Universitäts-Herzzentrum Freiburg • Bad Krozingen
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Tim Berger, Dr., +4976127028181, tim.berger@uniklinik-freiburg.de
- Recruiting
Universitätsklinikum Halle
Halle, Saxony-Anhalt, 06120
Gábor Szabó, Prof. Dr., +349345557271, Gabor.Szabo@uk-halle.de
- Recruiting
Universitätsklinikum Jena
Jena, Thuringia, 07747
Tulio Caldonazo, Dr., +49 36419322953, tulio.caldonazo@med.uni-jena.de
Marcus Winter, +49 36419396648, marcus.winter@med.uni-jena.de
- Recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Andreas Hoffmeier, Prof. Dr., +492518344506, andreas.hoffmeier@ukmuenster.de
Vladyslava Stasii, +492518344542, Vladyslava.Stasii@ukmuenster.de
- Recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Andreas Liebold, Prof. Dr., +4973150054303, Andreas.Liebold@uniklinik-ulm.de
André Peres, +4973150054406, andre.peres@uniklinik-ulm.de
About this study
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.
Read the 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
- Keywords
- Biomarker, Troponin, CK-MB, Perioperative Myocardial Infarction, LGE-cMRI
- Medical subject headings
- Heart Valve Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-surgery and 5 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start5 Sep 2023
- Primary completionSep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tulio Caldonazo, Jena University Hospital
- Investigators
- Tulio Caldonazo, Dr., Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066970
- Sponsor's protocol ID
- ZKSJ0156
- Acronym
- RORSCHACH
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet decided in which way and which data exactly will be shared with other researchers.
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.
PubMed 40918750
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06066970
- Acronym / sponsor ID
- RORSCHACH / ZKSJ0156
- Conditions
- Cardiac Valve Disease
- Keywords
- Biomarker, Troponin, CK-MB, Perioperative Myocardial Infarction, LGE-cMRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for isolated aortic or mitral valve surgery and exclusion of coronary artery disease.
Key inclusion criteria (3 listed)
- Indication for isolated aortic or mitral valve surgery
- Written informed consent
- Age ≥ 18 years
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation biomarker release and LGE-cMRI
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 40918750Caldonazo 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.
- Individual participant dataSharing planned: Undecided. It is not yet decided in which way and which data exactly will be shared with other researchers.
Related trials for Cardiac Valve Disease
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tulio Caldonazo, Dr. principal investigator
Jena University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Valve Disease, run by Jena University Hospital at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tulio Caldonazo, Dr. (+49 36419322953, tulio.caldonazo@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation biomarker release and LGE-cMRI (time frame: pre-surgery and 5 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.