Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium
Primary Purpose
Myocardial Ischemia
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Timi3 Transthoracic ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia focused on measuring Hibernating Myocardium, Blood Flow, Ultrasound, PET imaging
Eligibility 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
Sites / Locations
- UC San Francisco
Outcomes
Primary Outcome Measures
Change in myocardial blood flow from baseline to post ultrasound treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00655070
First Posted
April 3, 2008
Last Updated
April 2, 2012
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00655070
Brief Title
Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium
Official Title
Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
Keywords
Hibernating Myocardium, Blood Flow, Ultrasound, PET imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Timi3 Transthoracic ultrasound
Intervention Description
Low frequency ultrasound over the chest using Timi3 ultrasound device
Primary Outcome Measure Information:
Title
Change in myocardial blood flow from baseline to post ultrasound treatment
Time Frame
immediate post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Dae, MD
Organizational Affiliation
University of California at San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Timi3 Ultrasound on Myocardial Blow Flow in the Hibernating Myocardium
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