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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014