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

NCT ID: NCT00655070

Last Updated: 2012-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Myocardial Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Timi3 Transthoracic ultrasound

Low frequency ultrasound over the chest using Timi3 ultrasound device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael W Dae, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at San Francisco

Locations

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UC San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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H1644-31803-02

Identifier Type: -

Identifier Source: org_study_id

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