NCT00850486

Brief Summary

The purpose of this study is to verify the efficiency of the HyperQ technology compared with standard ECG analysis in detecting exercise induced ischemia in women who are referred to coronary angiography.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

February 24, 2009

Last Update Submit

February 24, 2009

Conditions

Ischemic Heart Disease

Keywords

womenischemic heart diseasehigh frequency ECGexercise stress testingsignal processingischemic heart disease in women

Outcome Measures

Primary Outcomes (1)

  • HyperQ results from the exercise test vs. angiography results

    every 25 patients

Interventions

Exercise test with HyperQ technologyDEVICE

High frequency components of the QRS complex within the ECG signal are analyzed off-line to provide an indication of ischemia induced depolarization abnormalities

Eligibility Criteria

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

You may qualify if:

  • A woman who was referred to angiography.
  • A woman who is able (i.e. no contraindications) to perform an exercise stress test
  • A woman who signed an informed consent form.

You may not qualify if:

  • Contraindications for an exercise test
  • Wolff-Parkinson-White (pre-excitation) syndrome.
  • Left Bundle branch block, Complete Right bundle branch block or QRS duration \> 120 ms, change in QRS morphology during exercise
  • Atrial Fibrillation or significant ventricular arrhythmia
  • Treatment with Digoxin
  • Pacemaker
  • Having taken beta blockers within 24 hours before the exercise test
  • Pregnancy or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Dan Tzivoni, Professor

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rosenmann, MD

CONTACT

972-2-6555974rosenmann@szmc.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations

IL(1)