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

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00266435
First received: December 15, 2005
Last updated: March 25, 2008
Last verified: March 2008
  Purpose

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.


Condition Phase
Cardiovascular Diseases
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Usefulness of the HyperQ Stress System in Routine Annual Screening Testing

Further study details as provided by Sheba Medical Center:

Enrollment: 371
Study Start Date: November 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Primary prevention program

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266435

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ehud Schwammenthal, Prof. Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00266435     History of Changes
Other Study ID Numbers: SHEBA-05-3693-ES-CTIL
Study First Received: December 15, 2005
Last Updated: March 25, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Asymptomatic subjects
Moderate to high risk for cardiovascular event

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014