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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01750450
First received: December 6, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Correlation between left ventricular pressure volume area (PVA) and aortic PVA [ Time Frame: day of procedure ] [ Designated as safety issue: No ]
    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%.


Enrollment: 65
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elective left heart cath
Patients undergoing elective left heart catheterization will be consented for this study

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adults 18 and over undergoing elective left heart catheterization

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to visualize ascending aorta using ultrasound
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01750450

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01750450     History of Changes
Other Study ID Numbers: 16494
Study First Received: December 6, 2012
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Pressure Volume Area
Pressure Flow Area
Myocardial Work

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014