Cardiac biomarkers for the quantification of myocardial damage after cardiac surgery - The RORSCHACH trial

Cardiac biomarkers are important components for diagnosing perioperative myocardial infarction (MI). Efforts to detect MI by biomarker-release only faced heavy criticism, because cardiac biomarker-release has also been observed in situations that are not always related to cell death (e.g., renal insufficiency, neurological diseases, and even after endurance exercise). This study correlates release patterns of all three classically used cardiac injury biomarkers (CK/CK-MB, Troponin T and I) with myocardial damage visualized by late gadolinium enhanced cardiac magnetic resonance imaging (LGE-cMRI) and also compares biomarkers among each other.

The RORSCHACH study is a prospective, multicenter, single-armed, non-blinded, non-controlled study evaluating cardiac biomarker release during elective aortic or mitral valve surgery and their correlation to perioperative myocardial damage as detected by MRI. Enrolled patients undergo routine monitoring including echocardiography, electrocardiography, cardiac biomarker analyses, and clinical symptom assessment preoperatively (within 24 h prior to surgery) and postoperative at predefined timepoints. LGE-cMRI is performed preoperatively and at least 5 days after surgery to clinically quantify any new myocardial damage. In total, 100 patients will be enrolled, whereby a drop-out rate of 15 % subsequently results in 85 patients necessary for final analysis. The primary endpoint is the correlation of the peak value of the respective biomarker with the amount of perioperatively induced myocardial damage quantified by LGE-cMRI.

The RORSCHACH trial will deliver the first comparative and quantitative information on the predictive value of the three classic cardiac injury markers used for the detection of new perioperative irreversible injury/MI in cardiac surgery.

Clinicaltrials.gov. NCT06066970. Registered on September 28th 2023.