NCT02661529

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

September 29, 2015

Last Update Submit

October 25, 2017

Conditions

Bidirectional Cardiovascular Shunt

Keywords

ShuntEchocardiogram

Outcome Measures

Primary Outcomes (1)

  • Degree of right atrial opacification on echocardiogram image

    The degree of right atrial opacification during echocardiogram will be rated with an image score; 0: poor/no opacification, 1: average opacification, 2: good opacification

    Day 1

Study Arms (2)

Transesophageal Echocardiogram

ACTIVE COMPARATOR

Patients undergoing an Transesophageal Echocardiogram (TEE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast

Procedure: Transesophageal Echocardiogram (TEE)Other: Saline/Air MixtureOther: Saline/Blood Mixture

Transthoracic Echocardiogram

ACTIVE COMPARATOR

Patients undergoing an Transthoracic Echocardiogram (TTE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast

Procedure: Transthoracic Echocardiogram (TTE)Other: Saline/Air MixtureOther: Saline/Blood Mixture

Interventions

Transesophageal Echocardiogram (TEE)PROCEDURE

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.

Transesophageal Echocardiogram
Transthoracic Echocardiogram (TTE)PROCEDURE

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.

Transthoracic Echocardiogram
Saline/Air MixtureOTHER

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.

Transesophageal EchocardiogramTransthoracic Echocardiogram
Saline/Blood MixtureOTHER

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.

Transesophageal EchocardiogramTransthoracic Echocardiogram

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects having clinically indicated transesophageal or transthoracic echocardiogram, as ordered by their physician to detect a shunt.

You may not qualify if:

  • Unwillingness to provide consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Ali MA, Hepinstall MJ, Cassidy CS, Lane CM, Pellikka PA, Thaden JJ, Pislaru SV, Kane GC. Agitated Blood-Saline Rather Than Agitated Air-Saline for Echocardiographic Shunt Studies. J Am Soc Echocardiogr. 2020 Aug;33(8):1032-1033. doi: 10.1016/j.echo.2020.03.014. Epub 2020 Jun 10. No abstract available.

    PMID: 32532644DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Garvan Kane, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D./Principal Investigator

Study Record Dates

First Submitted

September 29, 2015

First Posted

January 22, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)