跳至主要内容
临床试验/NCT01202045
NCT01202045撤回不适用

Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension

Paul Farand1 个研究点 分布在 1 个国家开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.

研究概览

简要总结

The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.

详细描述

Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.

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

  • At least one of the prespecified indirect sign of pulmonary arterial hypertension
  • Able to exercise on treadmill

排除标准

  • left ventricular dysfunction at rest
  • Absence of pulmonary regurgitant flow
  • Pregnancy or breastfeeding
  • Smoking with > 60 pack-year

结局指标

主要结局

Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.

时间窗: 5 years

Every patient will have both procedures; stress echocardiography and right heart catheterization. A positive stress echocardiography is defined as \>= 20 mmhg increase in the systolic pulmonary artery pressure (SPAP) (between rest and stress) or an absolute value \>= 55 mmhg. A positive right heart catheterization at rest is defined as a PAPm \>25mmhg, wedge \< 18 and pulmonary vascular resistances \>3 wood units. Stress catheterization will also be perform and is defined as a PAPm \> 30mmhg and wedge \<18 mm hg.

次要结局

  • Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP.(5 years)
  • Function of the left ventricle (left ventricular ejection fraction) at rest and at stress.(Follow up every year X 5)
  • Diastolic function at rest and at stress(follow up every year X 5)
  • Function of the right ventricle(Follow up every year X 5)

研究者

发起方
Paul Farand
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Paul Farand

MD

Université de Sherbrooke

研究点 (1)

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