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Enhancement of Contrast Opacification for Echocardiographic Imaging of the Right Heart and Shunts

NCT02661529 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-10-26

No results posted yet for this study

Summary

The study aims to answer whether the use of a mixture of blood and saline alone (limited air) provides the same degree of right-heart contrast enhancement as compared to the standard agitated saline (with air), during two types of echocardiograms.

Conditions

  • Bidirectional Cardiovascular Shunt

Interventions

PROCEDURE

Transesophageal Echocardiogram (TEE)

Transesophageal echocardiography (TEE) is a test that produces pictures of the heart. TEE uses high-frequency sound waves (ultrasound) to make detailed pictures of the heart and the arteries that lead to and from it. Unlike a standard echocardiogram, the echo transducer that produces the sound waves for TEE is attached to a thin tube that passes through the mouth, down the throat and into the esophagus. Because the esophagus is so close to the upper chambers of the heart, very clear images of those heart structures and valves can be obtained.

PROCEDURE

Transthoracic Echocardiogram (TTE)

An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of the heart. These echoes are turned into moving pictures of the heart that can be seen on a video screen. Transthoracic echocardiogram (TTE) is the most common type of echocardiogram. Views of the heart are obtained by moving the transducer to different locations on the chest or abdominal wall.

OTHER

Saline/Air Mixture

The Saline/Air mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection.

OTHER

Saline/Blood Mixture

The Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1.0 milliliters of blood agitated together in a syringe prior to injection.

Sponsors & Collaborators

Principal Investigators

  • Garvan Kane, MD, PhD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
105 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661529 on ClinicalTrials.gov