Use of Reactivated DEFINITY in Patients Undergoing Stress Echo
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 12/12/2018 |
| Start Date: | December 2016 |
| End Date: | May 31, 2019 |
| Contact: | Thomas Porter, MD |
| Email: | trporter@unmc.edu |
| Phone: | 402-559-8150 |
Use of Reactivated DEFINITY® in Patients Undergoing Stress Echo Purpose of the study: Each
patient undergoing a stress echocardiogram uses a full vial of DEFINITY® 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®
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® 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.
patient undergoing a stress echocardiogram uses a full vial of DEFINITY® 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®
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® 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.
Patients undergoing previously scheduled stress echocardiography with the primary
investigator as the supervising physician will be identified and consented. The standard
stress echocardiography procedure will be performed. Definity® will be removed from
refrigeration and agitated for 45 seconds to vaporize into its gaseous phase. One mL of
Definity® 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® 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 stress portion of the
procedure coinciding with image acquisition. Contrast enhanced echocardiography by standard
acoustic acquisition will be performed following stress for the indicated diagnostic purpose
of the test. By the end of the exam, the gaseous Definity® will have undergone manual
compression via manual pressure and condensed back to its liquid phase. At this point, the
compressed Definity® 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.
investigator as the supervising physician will be identified and consented. The standard
stress echocardiography procedure will be performed. Definity® will be removed from
refrigeration and agitated for 45 seconds to vaporize into its gaseous phase. One mL of
Definity® 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® 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 stress portion of the
procedure coinciding with image acquisition. Contrast enhanced echocardiography by standard
acoustic acquisition will be performed following stress for the indicated diagnostic purpose
of the test. By the end of the exam, the gaseous Definity® will have undergone manual
compression via manual pressure and condensed back to its liquid phase. At this point, the
compressed Definity® 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.
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®
- Pregnant women
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