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

Early Phase 1TerminatedNCT00655070

University of California, San Francisco9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Myocardial Ischemia

Interventions

Low frequency ultrasound over the chest using Timi3 ultrasound device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UC San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in myocardial blood flow from baseline to post ultrasound treatment

Time frame: immediate post treatment

Data from ClinicalTrials.gov

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