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The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

NCT00449579 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2015-04-17

No results posted yet for this study

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.

Conditions

  • Myocardial Ischemia

Interventions

DEVICE

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

Sponsors & Collaborators

  • BSP Biological Signal Processing Ltd.

    collaborator INDUSTRY

  • Assuta Hospital Systems

    lead OTHER

Principal Investigators

  • Haim Silber, MD · Maccabi Healthcare Services, Israel

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Completion
2007-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449579 on ClinicalTrials.gov