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

NCT ID: NCT00266435

Last Updated: 2008-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 371 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-08-31

Brief Summary

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Ehud Schwammenthal, Prof.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-05-3693-ES-CTIL

Identifier Type: -

Identifier Source: org_study_id