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临床试验/NCT01567748
NCT01567748已完成不适用

In-human Validation of a Technique for Measuring Central Aortic Hemodynamics With Peripheral Arterial Waveforms

University of Alberta1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Validate ITF Methodology

研究概览

简要总结

Central aortic blood pressure (BP) and flow are generally more informative about the health condition of the heart and the arterial system compared with BP measured in peripheral locations (e.g. arm or leg). However, their clinical impact has been limited due to the cost, risk and discomfort associated with their measurements. Peripheral BP is attractive because it can be measured relatively easily than central aortic BP. However, peripheral BP is not as useful as central aortic BP since the shape of its waveform is different from that of central aortic BP. The applicant recently developed two innovative methods, the "Individualized Transfer Functions (ITF)," which is able to estimate the central aortic BP waveform of a patient using the measurements of peripheral BP waveform(s). The methods were successfully validated using animal and simulated human subjects. The objective of the proposed research project is to examine the validity of these innovative methods in human subjects.

Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion healthcare-related cost in Canada every year. The proposed research project will make significant contribution in improving clinical care by the potential of ITF in detection and diagnostics of cardiovascular disease. In fact, the proposed research project is a key initial step towards our long-term research objective of non-invasive cardiovascular disease diagnostics. The success of the proposed research project will demonstrate that ITF can serve as a low-cost, non-invasive and convenient alternative for central aortic BP measurement, which can further be used for the development of detection and diagnostics methods for a number of cardiovascular diseases (e.g. aortic valve impairment and peripheral arterial disease) by virtue of the relevant health and disease conditions of central and peripheral arterial vessels that ITF can deliver.

详细描述

Central aortic blood pressure (BP) and flow are generally more informative about cardiac dynamics and global circulation compared with cardiovascular parameters measured in the periphery [1,2]. However, their clinical impact has been limited due to significant clinical risk and substantial cost associated with their measurements. Peripheral arterial BP's are easily obtained non-invasively, but they cannot serve as direct substitutes for central aortic BP due to the distortion of arterial BP waveform caused by pressure wave propagation and reflection. Recently, two innovative model-based methods, the "Individualized Transfer Functions (ITF)," have been developed by Dr. Hahn to estimate central aortic BP waveform using the measurements of peripheral BP waveform(s) [3-6]. These techniques have been validated in animal and simulated human subjects. The objective of the proposed research project is to 1) examine the feasibility and validity of these innovative methods in human subjects, and 2) compare the performance of these methods against direct peripheral BP and existing non-individualized (NITF) methods.

The proposed research project consists of two major parts: 1) collection of central aortic and peripheral BP data, and 2) evaluation of ITF methods using these data. BP data will be collected from the patients already undergoing procedures with cardiopulmonary bypass. Central aortic, radial and femoral BP waveforms will be simultaneously recorded. A non-invasive finger BP waveform will also be recorded. The pair of radial-femoral or finger-femoral BP recordings will be analyzed by the two-measurement ITF [3-5] to estimate individual-specific central aortic BP waveform. In addition, radial or finger BP recording will be analyzed by the single-measurement ITF [6] to estimate individual-specific central aortic BP waveform. The feasibility and validity of the methods in human subjects will be assessed by comparing the estimated central aortic BP waveforms with the measured central aortic BP waveforms. Its relative performance with respect to direct peripheral BP and existing NITF methods will be analyzed by comparing the difference between measured central aortic versus ITF-derived central aortic BP waveforms with those between measured central aortic versus direct peripheral and NITF-derived central aortic BP waveforms.

Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion healthcare-related cost in Canada every year [7]. The proposed research project will make significant contribution in improving clinical care through the use of ITF in detection and diagnostics of cardiovascular disease. In fact, the proposed research project is a key initial step towards our long-term research objective of non-invasive cardiovascular disease diagnostics. The success of the proposed research project will be a milestone to demonstrate that ITF can serve as minimally invasive and/or non-invasive approach whose individually estimated central aortic BP waveform and cardiovascular system model can be exploited for detection and diagnostics of a number of cardiovascular disease, e.g. aortic valve impairment and peripheral arterial disease, by virtue of diagnostically relevant health and disease conditions of central and peripheral arterial vessels that ITF can deliver.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Written informed consent
  • Age 18 through 80 years, inclusive
  • Scheduled for coronary artery bypass surgery with CPB

排除标准

  • Scheduled for heart surgery other than coronary artery bypass surgery
  • Females of childbearing potential
  • Emergency surgery
  • BMI > 35

结局指标

主要结局

Validate ITF Methodology

时间窗: Intra Operatively

We will collect the relevant circulatory (BP) data and apply these data to validate the Individualized Transfer Function (ITF) methodology

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barry Finegan

Principal Investigator, Clinical Professor, Department of Anesthesiology

University of Alberta

研究点 (1)

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