NCT00266435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

Enrollment Period

1.7 years

First QC Date

December 15, 2005

Last Update Submit

March 25, 2008

Conditions

Cardiovascular Diseases

Keywords

Asymptomatic subjectsModerate to high risk for cardiovascular event

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary prevention program

You may qualify if:

  • 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

You may not qualify if:

  • A subject who cannot or should not perform an exercise test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Ehud Schwammenthal, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 16, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

IL(1)