NCT01089777

Brief Summary

The study is an open prospective study of coronary flow preferably of the left anterior descending artery (LAD), by a Transthoracic Parametric Doppler (TPD) system during conventional exercise stress test. The system is a noninvasive non-imaging device designed to monitor coronary flow velocity and display the data continuously during exercise stress tests. The system enables continuous monitoring of coronary flow during resting, stress loading and recovery phases. The study intent is to improve the stress test predictive value for CAD.

Trial Health

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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

May 1, 2011

Enrollment Period

3.8 years

First QC Date

March 16, 2010

Last Update Submit

August 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Monitor coronary artery flow during exercise stress test.

    1-3 months following the stress test

Secondary Outcomes (1)

  • Improve CAD predictive power of stress testing

    1-3 months following the stress test

Interventions

Ultrasound Doppler monitoring throughout the stress test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Scheduled to exercise stress test

You may qualify if:

  • Age 18 years or older
  • Planned for ergometry test
  • Signed informed consent

You may not qualify if:

  • Excluded for stress test on a treadmill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular department, Carmel medical center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 19, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

August 5, 2014

Record last verified: 2011-05

Locations