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Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing

2017年1月9日 更新者:University of Chicago

Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors have referred them for a right heart catheterization (RHC). Heart catheterization involves inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to the heart (sometimes this procedure can be done through a vein in the groin instead). Once the catheter is in place, small instruments can be inserted into the catheter to measure the pressures in different areas of the heart. These measurements can help the doctor diagnose possible problems with the heart functioning.

The purpose of this study is to evaluate the measurements provided by a device, called Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. While the device has been approved for use in any patient, it remains possible that patients with PH will have differences in the way the device calculates measurements. In this study, the investigators will compare the in-the-body (right heart catheterization) measurements to the non-invasive, outside-body measurements provided by the NICOM device to evaluate any differences.

The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the right heart catheterization procedure that is scheduled as part of the patients' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.

研究概览

地位

撤销

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

We will enroll 100 consecutive patients referred to the Pulmonary Hypertension Center and scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH.

描述

Inclusion Criteria:

  • 18 years old and up
  • have Pulmonary Hypertension (PH)
  • Scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH

Exclusion Criteria:

  • unable or unwilling to give informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
subjects with PH undergoing right heart catheterization

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To determine the accuracy of a noninvasive method of measuring cardiac output as compared to the standard invasive approach using thermodilution in patients with pulmonary hypertension
大体时间:2 years
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stephen Archer, MD、University of Chicago

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年5月1日

初级完成 (预期的)

2014年5月1日

研究完成 (预期的)

2014年5月1日

研究注册日期

首次提交

2011年1月10日

首先提交符合 QC 标准的

2011年1月11日

首次发布 (估计)

2011年1月12日

研究记录更新

最后更新发布 (估计)

2017年1月11日

上次提交的符合 QC 标准的更新

2017年1月9日

最后验证

2017年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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