NCT00449579

Brief Summary

The main objective of this study is to determine the usefulness of the HyperQ™ System in improving the positive predictive value of conventional ECG stress testing. Patients who are referred for stress test will perform an ECG stress test on a treadmill, with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™ System. The results of the conventional test and the HyperQ™ data will be compared, using one of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and angiography) as gold standards. Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the conventional and HyperQ™ stress ECG in detecting myocardial ischemia.

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
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 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

August 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

April 17, 2015

Status Verified

October 1, 2006

First QC Date

March 19, 2007

Last Update Submit

April 16, 2015

Conditions

Myocardial Ischemia

Keywords

IschemiaMyocardialHF-ECG

Outcome Measures

Primary Outcomes (2)

  • ST changes

  • HyperQ results

Interventions

Excercise stress test with high frequency ECG recording (HyperQ™ System)DEVICE

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject referred to stress ECG
  • Subjects age ≥ 45
  • Subject signed an Informed Consent form

You may not qualify if:

  • Subject with contraindications for stress ECG
  • Subject with implantable pacemaker or defibrillator
  • Subject with LBBB
  • Subject with QRS duration ≥ 110 mSec
  • Subject with Wolff-Parkinson-White Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Silber Clinic

Kfar Saba, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Myocardial IschemiaIschemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Haim Silber, MD

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haim Silber, MD

CONTACT

09 7408811silber_h@mac.org.il

Nechi Almogy, MD

CONTACT

03 6474840nechi@bsp.co.il

Study Design

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

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

August 1, 2006

Study Completion

October 1, 2007

Last Updated

April 17, 2015

Record last verified: 2006-10

Locations

IL(1)