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

NCT02950493 | Terminated

• 1 other identifier: 0281-16-FB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Use of Reactivated DEFINITY® in or LUMASON Patients Undergoing Rest or Stress Echo Purpose of the study: Each patient undergoing a rest or stress echocardiogram uses a full vial of DEFINITY® or LUMASON contrast agent. During infusion, this often condenses back to its liquid phase due to manual pressure applied in the syringe. At this point, it is not optimal to be used at current ultrasound settings for stress echocardiography. This research project will test whether this condensed DEFINITY® or LUMASON can be reactivated by ultrasound using the same transducer used to image the patient. Eligibility: Same criteria as required for stress echo procedure. Interventions and Evaluations: Inject condensed DEFINITY® or LUMASON at end of stress test Follow Up: The patient would be observed by echo lab staff for half an hour following completion of the stress test. There would be no longitudinal follow up.

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 microsphere OTHER

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• Prior allergic reaction to Definity® or Lumason
• Pregnant women

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

perflutren

Study Officials

• Thomas R Porter, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)