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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00655070
First received: April 3, 2008
Last updated: April 2, 2012
Last verified: April 2012
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating

Resource links provided by NLM:


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 ]

Enrollment: 9
Study Start Date: April 2008
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Timi3 Transthoracic ultrasound
    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

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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00655070     History of Changes
Other Study ID Numbers: H1644-31803-02
Study First Received: April 3, 2008
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014