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

IF 2.5 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

IJC Heart and Vasculature Pub Date : 2025-08-28 DOI:10.1016/j.ijcha.2025.101781

Tulio Caldonazo , Marcus Winter , Michael Kiehntopf , René Aschenbach , Stephanie Gräger , Sebastian Reinartz , André Scherag , Ulrike Schumacher , Hristo Kirov , Ulf Teichgräber , Torsten Doenst , on behalf of the RORSCHACH Investigators and GermaN HeaRTS

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引用次数: 0

Abstract

Background

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.

Methods and analysis

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.

Discussion

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.

Study registration

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

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心脏手术后心肌损伤定量的心脏生物标志物-罗夏试验

背景：心脏生物标志物是诊断围手术期心肌梗死（MI）的重要组成部分。通过生物标志物释放来检测心肌梗死的努力只面临严厉的批评，因为心脏生物标志物释放也被观察到在与细胞死亡并不总是相关的情况下（例如，肾功能不全、神经系统疾病，甚至在耐力运动后）。本研究将三种常用的心脏损伤生物标志物（CK/CK- mb、肌钙蛋白T和肌钙蛋白I）的释放模式与晚期钆增强心脏磁共振成像（LGE-cMRI）显示的心肌损伤相关联，并相互比较生物标志物。RORSCHACH研究是一项前瞻性、多中心、单臂、非盲、非对照研究，评估选择性主动脉瓣或二尖瓣手术期间心脏生物标志物的释放及其与围术期心肌损伤的相关性，通过MRI检测。入组患者术前（术前24小时内）和术后在预定时间点接受常规监测，包括超声心动图、心电图、心脏生物标志物分析和临床症状评估。术前和术后至少5天进行LGE-cMRI，以临床量化任何新的心肌损伤。总共有100名患者将被纳入研究，15%的退出率导致85名患者需要进行最终分析。主要终点是各自生物标志物的峰值与LGE-cMRI量化的围术期心肌损伤量的相关性。RORSCHACH试验将首次提供三种经典心脏损伤标志物的预测价值的比较和定量信息，用于心脏手术中新的围手术期不可逆损伤/MI的检测。研究registrationClinicaltrials.gov。NCT06066970。于2023年9月28日注册。

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来源期刊

IJC Heart and Vasculature Medicine-Cardiology and Cardiovascular Medicine

CiteScore

4.90

自引率

10.30%

发文量

216

审稿时长

56 days

期刊介绍： IJC Heart & Vasculature is an online-only, open-access journal dedicated to publishing original articles and reviews (also Editorials and Letters to the Editor) which report on structural and functional cardiovascular pathology, with an emphasis on imaging and disease pathophysiology. Articles must be authentic, educational, clinically relevant, and original in their content and scientific approach. IJC Heart & Vasculature requires the highest standards of scientific integrity in order to promote reliable, reproducible and verifiable research findings. All authors are advised to consult the Principles of Ethical Publishing in the International Journal of Cardiology before submitting a manuscript. Submission of a manuscript to this journal gives the publisher the right to publish that paper if it is accepted. Manuscripts may be edited to improve clarity and expression.