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

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ClinicalTrials.gov Identifier: NCT00655070
Recruitment Status : Terminated
First Posted : April 9, 2008
Last Update Posted : April 4, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Device: Timi3 Transthoracic ultrasound Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating
Study Start Date : April 2008
Primary Completion Date : April 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Timi3 Transthoracic ultrasound
    Low frequency ultrasound over the chest using Timi3 ultrasound device

Outcome Measures

Primary Outcome Measures :
  1. Change in myocardial blood flow from baseline to post ultrasound treatment [ Time Frame: immediate post treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655070


Locations
United States, California
UC San Francisco
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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00655070     History of Changes
Other Study ID Numbers: H1644-31803-02
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012

Keywords provided by University of California, San Francisco:
Hibernating Myocardium
Blood Flow
Ultrasound
PET imaging

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases