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临床试验/NCT06689098
NCT06689098已完成不适用

Diagnostic Accuracy of Magnetocardiography in Inflammatory Cardiomyopathies: A Comparison With Noninvasive Cardiovascular Magnetic Resonance (CMR) and Invasive Endomyocardial Biopsy

German Heart Institute1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2022年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
330
试验地点
1
主要终点
Accurate diagnosis of inflammatory cardiomyopathy

研究概览

简要总结

Accurate and rapid screening is an unmet medical need to address the increasing demand for advanced diagnostic workup in patients with suspected cardiomyopathy. Due to an overwhelmed health care system, advanced imaging is not always immediately available leading to underdiagnosis and progression of cardiomyopathies to advanced stages and sudden death. The investigator's recently demonstrated in a retrospective study that magnetocardiography (MCG) could be a suitable tool to detect inflammatory and other types of cardiomyopathies in a highly effective manner and without any safety issues. In this study, the investigator's test diagnostic accuracy of MCG prospectively.

详细描述

Inflammatory cardiomyopathy is one of the most common causes of sudden cardiac death in young adults, as it frequently remains undetected. Also, it is a common cause of heart failure, which may lead to circulatory collapse, requiring mechanical circulatory support or heart transplant. Some patients may require immunosuppression in addition to standard heart failure therapy. Early initiation of therapy is crucial for optimal outcomes.

Inflammatory disease of the heart muscle/inflammatory cardiomyopathy can be challenging to diagnose because it often requires expensive, time intense, and sometimes invasive testing, such as cardiac magnetic resonance imaging (MRI) and endomyocardial biopsies (EMB). As a result, there is an unmet clinical need for low threshold diagnostic screening in patients with suspected cardiomyopathy.

In this study the investigator's evaluate the diagnostic accuracy of magnetocardiography (MCG) in detecting inflammatory and other types of cardiomyopathy. Diagnostic accuracy will be compared to results from advanced imaging (cardiac magnetic resonance (CMR) imaging and/or positron emission computed tomography (PET-CT)) and where available to histology from endomyocardial biopsy/EMB.

CMR provides comprehensive structural and functional data while detecting consequences of inflammation, such as edema and late gadolinium enhancement. PET-CT detects the level of activity and the extent of inflammation through measurement of glucose metabolism. However, it cannot be applied frequently because of the associated radiation exposure. EMB is the gold standard for definitive diagnosis of inflammatory cardiomyopathy and is crucial for initiation of immunosuppressive therapy, as active viral infection should be excluded. However, the limited diagnostic yield due to sampling error and risk of potential complications limit its use to selected cases where there is a high suspicion that specific treatment may be necessary.

MCG is based on detecting the movement of ions in the myocardium. When an action potential in the heart is generated, it creates voltage changes and consequently an electromagnetic field. The strength and direction of this field are affected by the flow of ions both inside and outside the cells. Typically, the magnetic field produced by the heart ranges from from 10-15 to 11-11 Tesla.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with angina-like symptoms after exclusion of coronary artery disease

排除标准

  • Presence of intracardiac metal devices and prior treatment with immunosuppressants

结局指标

主要结局

Accurate diagnosis of inflammatory cardiomyopathy

时间窗: MCG is obtained at the time of clinical presentation. Accuracy of diagnosis by MCG is tested with the current diagnostic gold standard methods: CMR, PET-CT and/or EMB, when clinically indicated.

The main outcome is the correct diagnosis of an inflammatory cardiomyopathy, the noninvasive gold standard cardiac magnetic resonance imaging or invasive gold standard endomyocardial biopsy.

次要结局

未报告次要终点

研究者

发起方
German Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bettina Heidecker

Head of Heart Failure and Cardiomyopathy

German Heart Institute

研究点 (1)

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