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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Echocardiography
• Intervention / Treatment: Other: perflutren lipid microsphere

Detailed Description

Patients undergoing previously scheduled rest or stress echocardiography with the primary investigator as the supervising physician will be identified and consented. The standard stress echocardiography procedure will be performed. Definity® or LUMASON will be removed from refrigeration and agitated for 45 seconds to vaporize into its gaseous phase. One mL of Definity® or LUMASON will then be diluted in 29 mL of isotonic, sterile saline. Patients will undergo baseline echocardiography followed by stress with either dobutamine or exercise. Standard Definity® or LUMASON will be injected intravenously into the subject via peripheral intravenous access obtained prior to the study by a registered nurse at the end of the rest or stress portion of the procedure coinciding with image acquisition. Contrast enhanced echocardiography by standard acoustic acquisition will be performed following rest or stress for the indicated diagnostic purpose of the test. By the end of the exam, the gaseous Definity® or LUMASON will have undergone manual compression via manual pressure and condensed back to its liquid phase. At this point, the compressed Definity® or LUMASON will be given intravenously with repeated transthoracic echocardiography. During this second round of image acquisition, real time (RT) imaging (35 Hertz) and 1:1 triggered (Tr) end systolic imaging at various mechanical indices (MI's) up to 1.2 will be performed in standard transthoracic echocardiography windows. Acoustic Intensity (AI) within the left ventricular (LV) cavity, the anterior myocardium (AM) and inferolateral myocardium (ILM) at end systole will be obtained at each MI setting with real time or triggered imaging. Differences in AI between Tr and RT imaging within the AM and ILM at each MI will be used to quantify bubble activation/destruction. Following image acquisition, the patient will be observed for 30 minutes by echo lab staff with nearby resuscitative equipment per current protocol. If no adverse events are noted, the patient will then be dismissed.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Higgins, MD; Phone Number: 402-559-6504; Email: jvhiggin@unmc.edu
• Study Contact Backup: Name: Thomas R Porter, MD; Phone Number: 402-559-8150; Email: trporter@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Thomas R Porter, MD; Phone Number: 402-559-8150; Email: trporter@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single group, one arm study group; Compare echocardiograph imaging efficacy of active Definity or Lumason (perflutren lipid microsphere) with compressed Definity or Lumason.	Other: perflutren lipid microsphere; Definity and Lumason are tools for diagnosis used in echocardiography. Compare activated Definity or Lumason with compressed Definity or Lumason.; Other Names: DEFINITY; LUMASON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Adverse Events regarding reading of echocardiography	Monitor for adverse events	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.

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: September 14, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (Estimated): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 0281-16-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No