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临床试验/NCT07083115
NCT07083115Enrolling By Invitation不适用

Developing MRI Technologies for Atrial Fibrillation

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月16日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Image quality

研究概览

简要总结

To measure image quality of damaged areas of the heart in patients with Atrial fibrillation using the contrast Gadopiclenol vs conventional Gadolinium-based contrast agents(GBCA)

详细描述

With the use of gadolinium-based contrast agents (GBCA), cardiac MRI has become the clinical gold standard in tissue characterization of fibrosis in the ventricular myocardium. More recently, contrast enhanced cardiac MRI using standard class I GBCA was proposed to reveal fibrosis in the left atrium to characterize AF via the DECAF and DECAF II studies.

Unfortunately, the results were negative with the culprit reason being the lack of clear visualization of the enhanced regions. This claim was substantiated in a recent 2024 Langendorff (reanimated ex vivo) human heart study in AF patients showing clearly the presence of fibrosis with microscopy and more importantly it showed contrast enhanced MRI can also visualize the fibrosis an equivalent 4x dose of GBCA. However, the study was performed ex vivo and no follow up in vivo study was performed to test the in vivo viability. Thus the investigators propose the unique use of standard dose of Gadopiclenol (Elucerim), a novel high relaxivity agent, contrast enhanced MRI to scan AF patients to identify and characterize areas of fibrosis and validate the electrophysiology dysfunction in those same regions.

It is hypothesized that the Gadopiclenol can provide an improved enhancement as compared to the use of conventional GBCA like Gadovist and potentially can better reveal the AF fibrotic infiltrate. Furthermore, the higher contrast to noise ratio (CNR) of the lesion will support a significantly higher spatial resolution and potentially enable sub-mm high resolution imaging.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Diagnosis of Atrial Fibrillation

排除标准

  • Contraindications to MRI
  • Contraindications to Gadolinium based contrast agents.

结局指标

主要结局

Image quality

时间窗: At completion of each MRI

To demonstrate standard dose (0.05mmol/kg) of Gadopiclenol cardiac MRI significantly improves the enhancement of AF compared with standard dose (0.1mmol/kg) of conventional GBCA agents. Research MRI data will be reviewed against any standard clinical MRI available in the patient's medical record.

次要结局

  • High resolution Cardiac MRI for improved imaging of AF(At completion of each MRI)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Nguyen

Director of Cardiovascular Innovation Research Center

The Cleveland Clinic

研究点 (1)

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