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

Myocardial Ischemia Clinical Trial

Official title:

Evaluation of the Effect of T3US on Myocardial Blow Flow in the Hibernating

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00655070
• Other study ID #: H1644-31803-02
• Status: Terminated
• Phase: Phase 0
• First received: April 3, 2008
• Last updated: April 2, 2012
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
United States	UC San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial blood flow from baseline to post ultrasound treatment		immediate post treatment	No