Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium
Early Phase 1
Terminated
- Conditions
- Myocardial Ischemia
- Registration Number
- NCT00655070
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in myocardial blood flow from baseline to post ultrasound treatment immediate post treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UC San Francisco
🇺🇸San Francisco, California, United States