Skip to main content
Clinical Trials/NCT02088320
NCT02088320CompletedNot Applicable

Measurement of Pulmonary Transit Time by Echocardiography: Comparison With Cardiac MRI

Vanderbilt University1 site in 1 country17 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
17
Locations
1
Primary Endpoint
1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a 'peak-to-peak' method

Study Overview

Brief Summary

The focus of the present study is to further develop an echocardiographic technique to measure cardiopulmonary transit time (PTT) and pulmonary blood volume (PBV) using ultrasound contrast.

The Specific Aims for the present study are as follows:

  1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a 'peak-to-peak' method
  2. To further quantify the relationship between echocardiographically-derived PTT, using Optison, and existing echocardiographic methods used to determine ventricular function
  3. To measure the reproducibility of echocardiographically-based PTT using Optison.

Detailed Description

Study Procedures The measurement of PTT and PBV has been described in detail in our prior protocol. These calculations and techniques are identical for the current study. In addition, we may place additional regions of interest (ROIs) during the off-line analysis, but this step would not influence the data acquisition during the TEE or the TEE procedure itself.

Note that placement of a peripheral intravenous (IV) catheter is standard-of-care for patients undergoing a TEE.

Acquisition and Analysis of Data:

The following is the anticipated flow of data acquisition and analysis:

  1. Prior to or upon arrival to the TEE Suite, prospective patients will be screened by study personnel for informed consent.
  2. After informed consent is obtained, the patient will undergo a focused TTE in the TEE Holding Room prior to the TEE. One or two doses of echocardiographic contrast will be administered to obtain PTT via TTE to facilitate comparison to PTT derived from TEE (Specific Aim #3). Prior to ultrasound contrast administration, an agitated saline injection will be given if intra-cardiac shunt is suggested by color Doppler evaluation. If a shunt is present, contrast would not be administered and the patient would be unenrolled from the study.
  3. During the TEE, under direct supervision of an attending cardiac anesthesiologist and/or an attending cardiologist, up to 2 additional doses of echocardiographic contrast would be administered. A sub-set of patients will receive 2 doses to facilitate comparison of PTT obtained from different views (Specific Aim #2). This is analogous to our previous protocol in which multiple doses of contrast are administered in order to assess reproducibility of PTT measurements.
  4. As part of standard-of-care, all patients that have completed a TEE are monitored in the TEE Suite for at least 30 minutes including assessment of blood pressure, heart rate, and oximetry.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female sex, age >18 years who are having an echocardiogram done for clinical reasons. Based on the potential for further support of our work, this may expand to include volunteers who would otherwise not be undergoing an echocardiogram.
  • Negative pregnancy test for women of childbearing potential
  • If eligible for cMRI, estimated glomerular filtration rate (eGFR) of > 30 mL/min
  • If eligible for cMRI, cMRI checklist obtained
  • Able to give informed consent

Exclusion Criteria

  • Unable to give informed consent
  • Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
  • Currently participating in another clinical treatment trial
  • Known allergic reaction to Optison ultrasound contrast
  • If eligible for cMRI, known allergic reaction to cMRI contrast
  • If eligible for cMRI, contraindication to cMRI
  • If eligible for cMRI, pre-cMRI eGFR < 30 mL/min
  • Pregnancy/Nursing

Outcomes

Primary Outcomes

1. To compare echocardiography-based PTTs and cardiac MRI-based PTTs obtained using a 'peak-to-peak' method

Time Frame: This will be assessed at the study visit. This study only have one study visit per patient.

Secondary Outcomes

  • 2. To further quantify the relationship between echocardiographically-derived PTT, using Optison, and existing echocardiographic methods used to determine ventricular function(This will be assessed at the study visit. This study only have one study visit per patient.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenneth Monahan

Assistant Professor

Vanderbilt University

Study Sites (1)

Loading locations...

Similar Trials