Myocardial Ischemia
Conditions
Keywords
Hibernating Myocardium, Blood Flow, Ultrasound, PET imaging
Brief summary
The purpose of this study is to evaluate whether the use application of low frequency ultrasound, administered by the Timi3 ultrasound device, increases myocardial blood flow to the heart, in subjects with reduced myocardial blood flow at rest (hibernating myocardium). The primary endpoint of the trial is to assess the increase in myocardial blood flow from baseline to post Timi3 Ultrasound treatment in a hypoperfused region of myocardium. Positron emission tomography (PET) imaging will be used to noninvasively evaluate cardiac blood flow. The hypothesis is that ultrasound increases blood flow in hibernating myocardium.
Interventions
DEVICETimi3 Transthoracic ultrasound
Low frequency ultrasound over the chest using Timi3 ultrasound device
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>/= 18 years * Must have reversible resting ischemia, resting non-reversible blood flow defect, or stress-induced ischemia. * Females with childbearing potential must not be pregnant at the time of the study * Must provide written informed consent
Exclusion criteria
* Unable or unwilling to cooperate with study procedures * Currently enrolled in another clinical study for which the follow-up period is not complete
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in myocardial blood flow from baseline to post ultrasound treatment | immediate post treatment |
Countries
United States
Outcome results
None listed