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

NCT01750450 | Completed

• 1 other identifier: 16494
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Pressure Volume Area; Pressure Flow Area; Myocardial Work

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

Elective left heart cath

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 and over undergoing elective left heart catheterization

You may qualify if:

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

You may not qualify if:

• Unable to visualize ascending aorta using ultrasound

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 17, 2012
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

US (1)