Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium

University of California San Francisco (UCSF)

Status and phase: Terminated; Early Phase 1

Conditions: Myocardial Ischemia

Treatments: Device: Timi3 Transthoracic ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT00655070

H1644-31803-02

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)