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

This study is currently recruiting participants.

Verified by University of California, San Francisco, February 2009

First Received: April 3, 2008 Last Updated: February 12, 2009 History of Changes

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00655070

Purpose

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.

Condition	Intervention	Phase
Myocardial Ischemia	Device: Timi3 Transthoracic ultrasound	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Change in myocardial blood flow from baseline to post ultrasound treatment [ Time Frame: immediate post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	105
Study Start Date:	April 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Low frequency ultrasound over the chest using Timi3 ultrasound device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655070

Contacts

Contact: Catherine Knize

415-502-1307

knizek@medicine.ucsf.edu

Locations

United States, California
UC San Francisco	Recruiting
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Michael W Dae, MD

University of California at San Francisco

More Information

No publications provided

Responsible Party:	University of California at San Francisco ( Michael W. Dae, M.D. )
Study ID Numbers:	H1644-31803-02
Study First Received:	April 3, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00655070 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Hibernating Myocardium
Blood Flow
Ultrasound
PET imaging

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Cocaine

Additional relevant MeSH terms:

Heart Diseases
Pathologic Processes
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on September 09, 2009