Stress EchocardiographyNCT02950493
Use of Reactivated DEFINITY or LUMASON in Patients Undergoing Rest or Stress Echocardiography
A study testing perflutren lipid microsphere in people with Stress Echocardiography, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stress Echocardiography
- What is being tested?
- perflutren lipid microsphere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or older at screening
- Clinically indicated stress echocardiography to take place at the UNMC echocardiography laboratory
Who cannot join
- Prior allergic reaction to Definity® or Lumason
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Echocardiography
- Being tested
- perflutren lipid microsphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perflutren lipid microsphereOther
Also called DEFINITY, LUMASON
Definity and Lumason are tools for diagnosis used in echocardiography. Compare activated Definity or Lumason with compressed Definity or Lumason.
| Study group | Role | What they receive |
|---|---|---|
| Single group, one arm study group | Other | Compare echocardiograph imaging efficacy of active Definity or Lumason (perflutren lipid microsphere) with compressed Definity or Lumason. Receives: Other: perflutren lipid microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic index
Acoustic index during realtime and triggered imaging between compressed Definity or Lumason and activated Definity or Lumason
Measured: 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
Monitor for adverse events
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start6 Apr 2017
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: In none of the patients could acoustic activation be produced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress EchocardiographyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas R Porter, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950493
- Sponsor's protocol ID
- 0281-16-FB
- Status last verified
- Oct 2024
- First submitted
- 14 Sep 2016
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Reactivated DEFINITY or Lumason in Patients Undergoing Rest or Stress Echocardiography
- ClinicalTrials.gov ID
- NCT02950493
- Acronym / sponsor ID
- 0281-16-FB
- Conditions
- Stress Echocardiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In none of the patients could acoustic activation be produced
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group, one arm study group | Other | Other: perflutren lipid microsphereCompare echocardiograph imaging efficacy of active Definity or Lumason (perflutren lipid microsphere) with compressed Definity or Lumason. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years of age or older at screening
- Clinically indicated stress echocardiography to take place at the UNMC echocardiography laboratory
Key exclusion criteria (2 listed)
- Prior allergic reaction to Definity® or Lumason
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perflutren lipid microsphereAlso: DEFINITY, LUMASONDefinity and Lumason are tools for diagnosis used in echocardiography. Compare activated Definity or Lumason with compressed Definity or Lumason. | Other | Single group, one arm study group |
Primary outcome
Acoustic index
Time frame: 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.
Acoustic index during realtime and triggered imaging between compressed Definity or Lumason and activated Definity or Lumason
1 secondary outcome
Clinical Adverse Events regarding reading of echocardiography
Time frame: 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.
Results and safety
The study was stopped early (reason given: In none of the patients could acoustic activation be produced). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No. There is no plan to share data.
Related trials for Stress Echocardiography
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
RecruitingObservational study
Exercise Phenotyping Prior to Chemotherapy in Newly Diagnosed Multiple Myeloma (MM-Exercise)
Exercise Behavior, Multiple Myeloma
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases
RecruitingObservational study
Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
Obstructive Coronary Artery Disease, Left Ventricular Hypertrophy
Not yet recruitingObservational study
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
Heart Failure With Preserved Ejection Fraction, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Porter, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perflutren lipid microsphere in people with Stress Echocardiography, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In none of the patients could acoustic activation be produced). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic index (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.