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临床试验/NCT04856059
NCT04856059招募中不适用

Fabry Cardiomyopathy: Identification of Early Myocardial Structural and Tissue Abnormalities Using Multiparametric MRI

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Major Adverse Cardiac Events (MACE)

研究概览

简要总结

This study will evaluate whether cardiac MRI T1 and T2 mapping improves our ability to detect early abnormalities in the heart in patients with Fabry disease and identify patients at increase risk of adverse events.

详细描述

Fabry disease is an inherited disorder that affects many organs in the body, including the heart. Men and women are both affected, with average life expectancy reduced by 10-20 years. The heart muscle can become thick and scarred in over half of patients, eventually resulting in heart failure, abnormal rhythm and death. The focus of this study will be on improving the detection of early heart disease before irreversible damage has occurred in order to improve patient outcomes.

It is hypothesized that new cardiac MRI techniques called T1 and T2 mapping will improve the ability to detect early abnormalities in the heart. Early detection of cardiac disease may enable a personalized treatment approach, potentially improving patient outcomes. The results of the study will identify which patients might benefit from early initiation of treatment to prevent bad outcomes in the future by using cardiac MRI to identify those at higher risk.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Fabry disease;
  • Age ≥ 18 years.

排除标准

  • History of myocardial infarction;
  • Contraindication to MRI.

研究组 & 干预措施

Cardiac MRI, ECG and Blood Biomarkers

Other

Additional sequences will be performed during routine clinical cardiac MRI and additional blood samples will be collected during routine blood work.

干预措施: Cardiac MRI, ECG/Holter and Blood Biomarkers (Diagnostic Test)

结局指标

主要结局

Major Adverse Cardiac Events (MACE)

时间窗: 5 years

MACE will be assessed as a composite endpoint defined by the development on one or more of events such as sustained ventricular tachycardia (VT), severe bradycardia, heart failure hospitalization and cardiac death.

次要结局

  • The FAbry STabilization indEX (FASTEX) score(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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