Cardiac biomarkers for the quantification of myocardial damage after cardiac surgery - The RORSCHACH trial.
Tulio Caldonazo, Marcus Winter, Michael Kiehntopf...
https://pubmed.ncbi.nlm.nih.gov/40918750/Actively Recruiting
Led by Jena University Hospital · Updated on 2025-09-26
100
Participants Needed
5
Research Sites
17 weeks
Total Duration
This research aims to understand how the release of specific heart-related proteins, called cardiac biomarkers troponin I, troponin T, and CK-MB, relates to actual heart muscle damage in patients undergoing heart valve surgery. The study focuses on patients without significant coronary artery disease and seeks to clarify how these biomarkers compare in their timing and levels after surgery. Findings may influence international guidelines on diagnosing heart damage after cardiac procedures. The study observes patients having isolated aortic or mitral valve surgery and measures the release of the three cardiac biomarkers during the recovery period. It compares these biomarker levels with traditional diagnostic methods like clinical symptoms, ECG, echocardiography, and advanced heart imaging using magnetic resonance imaging LGE-cMRI. The imaging is done before surgery and five days afterward to detect any heart muscle injury. Participants will undergo clinical evaluations, ECGs, echocardiography, and blood tests to track biomarker levels around the surgery. They will also have magnetic resonance imaging before surgery and at five days post-surgery to visualize heart muscle damage. Researchers will analyze how the biomarker releases correlate with imaging findings and clinical assessments. The study helps improve understanding of heart injury detection during and after valve surgery and lasts through the immediate postoperative period.
CONDITIONS
Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
T
Tulio Caldonazo, Dr.
M
Marcus Winter
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Jena University Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration (varies per participant)
Participants undergo elective isolated heart valve surgery followed by standard post-operative monitoring including clinical assessments, ECG, and echocardiography.
1 surgery visit and several in-hospital assessments
Duration - Pre-surgery and up to 5 days post-surgery
Participants have cardiac biomarkers measured and undergo magnetic resonance imaging to quantify myocardial damage related to surgery.
2 visits (pre-surgery and 5 days post-surgery)
Duration - Up to 5 days post-surgery
Participants are observed for changes in biomarkers and clinical status following surgery to assess recovery and myocardial damage.
Additional assessments during hospital stay
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Tulio Caldonazo, Marcus Winter, Michael Kiehntopf...
https://pubmed.ncbi.nlm.nih.gov/40918750/Jena University Hospital
Lead Sponsor