- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750450
Validation of Peripheral Pressure Volume Loops and Ultrasound-derived "Cardiac Power" by Comparison With Invasive Left Ventricular Pressure Volume Loops
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (18 or older)
- Undergoing left heart catheterization
Exclusion Criteria:
- Unable to visualize ascending aorta using ultrasound
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Elective left heart cath
Patients undergoing elective left heart catheterization will be consented for this study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
day of procedure
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16494
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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