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OpenTrials
Completed

NCT Number: NCT01750450

Validation of Peripheral Pressure Volume Loops and Ultrasound-derived "Cardiac Power" by Comparison With Invasive Left Ventricular Pressure Volume Loops

The investigators will generate pressure-flow loops and pressure-volume loops from aortic and left ventricular pressure waveforms and Doppler (desc. aorta) flow waveforms and compare left ventricular to arterial pressure-flow and pressure-volume loops as well as to cardiac power from the USCOM 1A device. The goal of this study is to test the hypothesis that non-invasive estimates of cardiac pressure-volume work (derived from ultrasound-based measurements) correlate with invasive estimates.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

Extensive animal work by Suga et al. in the 1980s clearly demonstrate a relationship between left ventricular pressure volume area (PVA) and myocardial consumption of oxygen (MVO2).

PVA can be measured by combining radial artery pressures with ultrasound-derived estimates of aortic blood flow. Because the aorta and peripheral artery compartments are separated from the left ventricle by the aortic valve, the peripheral arterial pressures cannot perfectly approximate left ventricular pressures. However, because the majority of variation in the pressure volume loops is made up of changes in height and width (changes in the left ventricular end-diastolic curve are, by contrast, relatively small), both of which can be readily detected by changes in the peripheral arterial blood pressure tracing, this loss of information may be clinically insignificant.

USCOM, has developed a portable suprasternal Doppler probe (model 1A) capable of estimating left ventricular stroke volume; a unique feature of this device is its ability to utilize both stroke volume, heart rate, and mean arterial pressure in an attempt to measure cardiac power. This device has not been validated against invasive estimates of cardiac power.

Knowledge of MVO2 would be a useful clinical variable but is not widely available. The ability to non-invasively estimate MVO2 intraoperatively would give anesthesiologists the ability to measure the effect of hemodynamic interventions on myocardial consumption of oxygen and, when combined with stroke volume, estimate myocardial efficiency. Non-invasively estimates of MVO2 may also allow cardiologists a novel means of assessing the myocardium of patients with cardiovascular disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (18 or older)
  • Undergoing left heart catheterization

Exclusion criteria

  • Unable to visualize ascending aorta using ultrasound

Treatment and study plan

Primary outcomes

  1. Correlation between left ventricular pressure volume area (PVA) and aortic PVA

    Time frame: day of procedure

    The primary hypothesis of this study is that the slope of the regression line between left ventricular pressure volume area (PVA, as determined by simultaneous measurement of aortic outflow and left ventricular pressures) and aortic PVA (as determined by simultaneous measurement of aortic outflow and radial artery pressure) is not zero. The null hypothesis is that the probability that the slope of the regression line is different from a line with a slope of 0 is greater than 5%.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2012
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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