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The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing

NCT ID: NCT00266435

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-08-31

Brief Summary

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The main objective of this study is to compare the sensitivity and specificity of a new system for analyzing the electrocardiogram (ECG) to the sensitivity and specificity of a conservative treadmill test in asymptomatic subjects, classified by Framingham score as moderate to high risk. Subjects will perform a routine exercise test with the addition of another set of electrodes to record high resolution ECG. All subjects will perform a stress echocardiography. The result of the routine ECG analysis will be compared to the new system and to the echocardiography results.

Detailed Description

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Conditions

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Cardiovascular Diseases

Keywords

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Asymptomatic subjects Moderate to high risk for cardiovascular event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* A patient referred to annual screening check
* Classified as being at intermediate or high risk for the development of cardiovascular disease by the Framingham score.
* Signed an Informed Consent Form

Exclusion Criteria

* A subject who cannot or should not perform an exercise test.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Ehud Schwammenthal, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-05-3693-ES-CTIL

Identifier Type: -

Identifier Source: org_study_id