NCT00310622

Brief Summary

The purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia. The gold standard for ischemia will be the results of Angiography if performed, or Echocardiographic imaging, which was performed during the test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 1, 2007

Status Verified

February 1, 2007

First QC Date

April 2, 2006

Last Update Submit

February 28, 2007

Conditions

Myocardial Ischemia

Keywords

HyperQIschemiadobutamine

Outcome Measures

Primary Outcomes (1)

  • HyperQ Signal recorded during the DES Test

Secondary Outcomes (1)

  • DES Outcome/ Angiography

Interventions

HyperQ Signal recordingDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject referred to dobutamine stress Echocardiography
  • Subject signed informed consent

You may not qualify if:

  • Subjects with implantable Pacemakers or Defibrillators
  • Subjects with Wolff-Parkinson-White Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Shaarey Zedek Hospital

Jerusalem, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Myocardial IschemiaIschemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Rosenmann, MD

    Shaarey Zedek Hospital, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rosenman, MD

CONTACT

+972-50-8685923

Nechi Almogy, MD

CONTACT

+972-54-6602697nechi@bsp.co.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 2, 2006

First Posted

April 4, 2006

Study Start

March 1, 2006

Study Completion

February 1, 2007

Last Updated

March 1, 2007

Record last verified: 2007-02

Locations

IL(1)