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临床试验/ACTRN12621000936820
ACTRN12621000936820尚未招募未知

Assessment of subclinical right ventricular dysfunction in Systemic Sclerosis (SSc) using blood oxygen level dependent (BOLD) myocardial resonance imaging and strain echocardiography

Flinders Medical Centre0 个研究点目标入组 88 人开始时间: 2021年7月16日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
88

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Patient population:
  • -Male and female aged greater than/ equal to 18 years
  • -Confirmed diagnosis of systemic sclerosis
  • -Screen negative for PAH based on Australian Scleroderma Interest Group (ASIG) algorithm or normal mean PAP (8-20 mmHg; assessed by right heart catheterisation). (Screen negative implies NT-proBNP < 210 pg/ml and pulmonary function test demonstrating DLCO > 70% predicted with FVC/DLCO <1.8)
  • -Normal echocardiography.
  • -No history of cardiac disease (myocardial infarction, angina, cardiomyopathy/heart failure, pulmonary thromboembolism and significant valvular heart disease).
  • Normal healthy controls:
  • -Male and female aged greater than/ equal to 18 years
  • -No history of cardiac disease
  • -Normal screening echocardiogram (post consent) which includes assessment of left and right ventricular function, diastolic function and pulmonary artery pressures

排除标准

  • -Inability to provide informed consent
  • -Prior documented LV/RV systolic dysfunction.
  • -Presence of significant coronary artery disease (>50% stenosis).
  • -Contraindications of CMR, including:
  • o Extreme claustrophobia
  • o Implantable cardiac devices and other contra-indications to CMR (metal in eyes, intracranial clips)
  • o Inability to lie flat for one hour
  • -Contraindication to gadolinium, including:
  • o Estimated Glomerular Filtration Rate (eGFR) of <45mL/min/1.73m2
  • -Contraindications to adenosine, including:
  • o second or third degree atrioventricular block
  • o obstructive pulmonary disease
  • o dipyridamole use

研究者

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