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临床试验/NCT03545672
NCT03545672已完成不适用

EARLY Identification of MYOcardial Impairment in Primary Biliary Cholangitis

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2017年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119
试验地点
1
主要终点
The Incidence of Cardiac Events

研究概览

简要总结

Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently developed as a reliable modality to evaluate the cardiac tissue characteristics and functions. This study aims to investigate the cardiac status in PBC patients based on CMR.

详细描述

Primary biliary cholangitis (PBC) is a progressive and uncommon inflammatory autoimmune cholesteric liver disease,which will contribute to cirrhosis. Symptoms and course of primary biliary cholangitis can be diverse, wherefore the targets of the current treatment are focused on the prevention of end-stage liver disease. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. From our clinical practice, the cardiac structural abnormal can be found in certain patients with PBC detected by cardiovascular magnet resonance (CMR). CMR is the primary and emerging imaging modality for myocardial tissue characterization, and it is recommended as a gold standard for functional imaging and assessment. This three-center, multi-modality, prospective observational study plans to identify the type and the severity of cardiac changes in PBC.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • History or presence of other concomitant liver disease including:
  • cirrhosis or viral hepatitis;
  • Inherited metabolic liver disease;
  • Drug-induced liver injury;
  • Other systemic disease inducing liver change.
  • Subjects with life expectancy < 6 months.
  • Subjects with known ischemic/non-ischemic cardiomyopathy or abnormal in cardiac-related examinations.
  • Subjects with standard metallic contraindications to CMR (i.e., estimated glomerular filtration rate < 30 ml/min/1.73 m2, New York Heart Association functional capacity class IV)
  • Inclusion Criteria for Control group:
  • Absence of known systemic diseases
  • Normal examinations in CMR/Echo/ECG
  • Age between 18-80 years old.
  • Providing written informed consent
  • Exclusion Criteria:
  • Subjects with known heart disease including:
  • Documented coronary artery disease;
  • Ischemia/non-ischemia cardiomyopathy;
  • Other systemic disease inducing heart change.
  • Subjects with known liver disease including:
  • Viral hepatitis;
  • Inherited metabolic liver disease;
  • Drug-induced liver injury;
  • Other systemic disease inducing liver change.
  • Subjects with standard metallic contraindications to CMR

结局指标

主要结局

The Incidence of Cardiac Events

时间窗: 7 months after first CMR scanning

All PBC patients are followed up through telephone or by retrieving outpatient medical record systems. Cardiac events include: 1. cardiac death; 2. myocardial infarction; 3. hospitalization for unstable angina.

Quantitative Assessment in Cardiac Injury

时间窗: within 2 days of CMR scan

T1 mapping-derived extracellular volumes (ECV) were used to detect changes in the myocardium interstitial matrix. ECV was calculated according to the ECV formula consist of T1 mapping value.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Early Identification of Myocardial Impairment in PBC | 临床试验