NCT00655070

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Apr 2008

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

April 3, 2008

Last Update Submit

April 2, 2012

Conditions

Myocardial Ischemia

Keywords

Hibernating MyocardiumBlood FlowUltrasoundPET imaging

Outcome Measures

Primary Outcomes (1)

  • Change in myocardial blood flow from baseline to post ultrasound treatment

    immediate post treatment

Interventions

Timi3 Transthoracic ultrasoundDEVICE

Low frequency ultrasound over the chest using Timi3 ultrasound device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>/= 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

You may not qualify if:

  • Unable or unwilling to cooperate with study procedures
  • Currently enrolled in another clinical study for which the follow-up period is not complete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Michael W Dae, MD

    University of California at San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 9, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

December 1, 2010

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

US(1)