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

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT01750450
Collaborator
(none)
65
1
3.9
16.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    65 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Mar 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Elective left heart cath

    Patients undergoing elective left heart catheterization will be consented for this study

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult (18 or older)

    • Undergoing left heart catheterization

    Exclusion Criteria:
    • Unable to visualize ascending aorta using ultrasound

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Virginia
    ClinicalTrials.gov Identifier:
    NCT01750450
    Other Study ID Numbers:
    • 16494
    First Posted:
    Dec 17, 2012
    Last Update Posted:
    May 1, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by University of Virginia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2014