Trials Sponsors Conditions Drugs Pricing

Conditions

Stress Echocardiography

Outcome Measures

Primary Outcomes (1)

Acoustic index
Acoustic index during realtime and triggered imaging between compressed Definity or Lumason and activated Definity or Lumason
Data obtained at time of stress echo and all data will be acquired and study completed within 1 hour of stress echo or regular echo study. No follow up is needed or indicated.

Secondary Outcomes (1)

Clinical Adverse Events regarding reading of echocardiography
The data will be obtained within 30 minutes of the echocardiogram or stress echocardiogram. Any potential side effects will have occurred within this time frame as well.

Study Arms (1)

Single group, one arm study group

OTHER

Compare echocardiograph imaging efficacy of active Definity or Lumason (perflutren lipid microsphere) with compressed Definity or Lumason.

Other: perflutren lipid microsphere

Interventions

perflutren lipid microsphereOther

Definity and Lumason are tools for diagnosis used in echocardiography. Compare activated Definity or Lumason with compressed Definity or Lumason.

Also known as: DEFINITY, LUMASON

Single group, one arm study group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age or older at screening
Clinically indicated stress echocardiography to take place at the UNMC echocardiography laboratory

You may not qualify if:

Sponsors & Collaborators

University of Nebraska
Otherlead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

MeSH Terms

Interventions

perflutren

Study Officials

Thomas R Porter, MD
University of Nebraska
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

November 1, 2016

Study Start

April 6, 2017

Actual (reported)

Study Stopped

Use of Reactivated DEFINITY or LUMASON in Patients Undergoing Rest or Stress Echocardiography

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single group, one arm study group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Single group, one arm study group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations